Trial Outcomes & Findings for A Study to Compare the Pharmacokinetics (PK) of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152A (Test) or HFA-134A (Reference) in Healthy Participants Aged 18 to 55 Inclusive (NCT NCT06433908)
NCT ID: NCT06433908
Last Updated: 2026-01-12
Results Overview
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Results posted on
2026-01-12
Participant Flow
The study consisted of two cohorts: Cohort 1 (200 µg dose) and Cohort 2 (800 µg dose). Each cohort included two treatment sequences, "TRRT" and "RTTR," where T represents salbutamol delivered using HFA-152a MDI (test) and R represents salbutamol delivered using HFA-134a MDI (reference). Participants were randomized to 1 of the 2 treatment sequences within each cohort.
Participant milestones
| Measure |
Cohort 1: TRRT1
Healthy participants in Cohort 1 received TRRT1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 4, Day 7
|
Cohort 1: RTTR1
Healthy participants in Cohort 1 received RTTR1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 1, Day 10
|
Cohort 2: TRRT2
Healthy participants in Cohort 2 received TRRT2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 4, Day 7
|
Cohort 2: RTTR2
Healthy participants in Cohort 2 received RTTR2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 1, Day 10
|
|---|---|---|---|---|
|
Cohort 1 - Treatment Period 1 (Day 1)
STARTED
|
16
|
14
|
0
|
0
|
|
Cohort 1 - Treatment Period 1 (Day 1)
COMPLETED
|
16
|
14
|
0
|
0
|
|
Cohort 1 - Treatment Period 1 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Cohort 1 - Treatment Period 2 (Day 4)
STARTED
|
16
|
14
|
0
|
0
|
|
Cohort 1 - Treatment Period 2 (Day 4)
COMPLETED
|
16
|
14
|
0
|
0
|
|
Cohort 1 - Treatment Period 2 (Day 4)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Cohort 1 - Treatment Period 3 (Day 7)
STARTED
|
16
|
14
|
0
|
0
|
|
Cohort 1 - Treatment Period 3 (Day 7)
COMPLETED
|
15
|
13
|
0
|
0
|
|
Cohort 1 - Treatment Period 3 (Day 7)
NOT COMPLETED
|
1
|
1
|
0
|
0
|
|
Cohort 1 - Treatment Period 4 (Day 10)
STARTED
|
15
|
13
|
0
|
0
|
|
Cohort 1 - Treatment Period 4 (Day 10)
COMPLETED
|
15
|
13
|
0
|
0
|
|
Cohort 1 - Treatment Period 4 (Day 10)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Cohort 2 - Treatment Period 1 (Day 1)
STARTED
|
0
|
0
|
14
|
16
|
|
Cohort 2 - Treatment Period 1 (Day 1)
COMPLETED
|
0
|
0
|
14
|
16
|
|
Cohort 2 - Treatment Period 1 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Cohort 2 - Treatment Period 2 (Day 4)
STARTED
|
0
|
0
|
14
|
16
|
|
Cohort 2 - Treatment Period 2 (Day 4)
COMPLETED
|
0
|
0
|
13
|
16
|
|
Cohort 2 - Treatment Period 2 (Day 4)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
Cohort 2 - Treatment Period 3 (Day 7)
STARTED
|
0
|
0
|
13
|
16
|
|
Cohort 2 - Treatment Period 3 (Day 7)
COMPLETED
|
0
|
0
|
13
|
16
|
|
Cohort 2 - Treatment Period 3 (Day 7)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Cohort 2 - Treatment Period 4 (Day 10)
STARTED
|
0
|
0
|
13
|
16
|
|
Cohort 2 - Treatment Period 4 (Day 10)
COMPLETED
|
0
|
0
|
13
|
16
|
|
Cohort 2 - Treatment Period 4 (Day 10)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: TRRT1
Healthy participants in Cohort 1 received TRRT1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 4, Day 7
|
Cohort 1: RTTR1
Healthy participants in Cohort 1 received RTTR1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 1, Day 10
|
Cohort 2: TRRT2
Healthy participants in Cohort 2 received TRRT2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 4, Day 7
|
Cohort 2: RTTR2
Healthy participants in Cohort 2 received RTTR2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 1, Day 10
|
|---|---|---|---|---|
|
Cohort 1 - Treatment Period 3 (Day 7)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Cohort 1 - Treatment Period 3 (Day 7)
Physician Decision
|
0
|
1
|
0
|
0
|
|
Cohort 2 - Treatment Period 2 (Day 4)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Compare the Pharmacokinetics (PK) of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152A (Test) or HFA-134A (Reference) in Healthy Participants Aged 18 to 55 Inclusive
Baseline characteristics by cohort
| Measure |
Cohort 1: TRRT1
n=16 Participants
Healthy participants in Cohort 1 received TRRT1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 4, Day 7
|
Cohort 1: RTTR1
n=14 Participants
Healthy participants in Cohort 1 received RTTR1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 1, Day 10
|
Cohort 2: TRRT2
n=14 Participants
Healthy participants in Cohort 2 received TRRT2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 4, Day 7
|
Cohort 2: RTTR2
n=16 Participants
Healthy participants in Cohort 2 received RTTR2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 1, Day 10
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
18 to 55 years
|
16 Participants
n=9 Participants
|
14 Participants
n=6 Participants
|
14 Participants
n=9 Participants
|
16 Participants
n=17 Participants
|
60 Participants
n=16 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
10 Participants
n=9 Participants
|
5 Participants
n=17 Participants
|
33 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
11 Participants
n=17 Participants
|
27 Participants
n=16 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
2 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=9 Participants
|
14 Participants
n=6 Participants
|
13 Participants
n=9 Participants
|
16 Participants
n=17 Participants
|
56 Participants
n=16 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)Population: Pharmacokinetic Population included all participants in the Full Analysis Set who had at least 1 non-missing assessment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=29 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=29 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30])
|
156.41 Hour * Picogram per Milliliter (h*pg/mL)
Interval 135.32 to 180.79
|
162.11 Hour * Picogram per Milliliter (h*pg/mL)
Interval 141.93 to 185.15
|
PRIMARY outcome
Timeframe: At pre-dose, 3, 5, 10, 15, 20, 30, 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)Population: Pharmacokinetic Population
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity])
|
5734.92 h*pg/mL
Interval 5214.16 to 6307.68
|
4431.63 h*pg/mL
Interval 4102.67 to 4786.97
|
PRIMARY outcome
Timeframe: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)Population: Pharmacokinetic Population
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Maximum Observed Plasma Concentration (Cmax)
|
639.28 Picogram per milliliter (pg/mL)
Interval 578.69 to 706.2
|
518.51 Picogram per milliliter (pg/mL)
Interval 463.91 to 579.53
|
PRIMARY outcome
Timeframe: At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)Population: Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=29 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30])
|
443.33 Hour * Picogram per Milliliter (h*pg/mL)
Interval 374.78 to 524.43
|
467.88 Hour * Picogram per Milliliter (h*pg/mL)
Interval 393.39 to 556.47
|
PRIMARY outcome
Timeframe: At pre-dose, 3, 5, 10, 15, 20, 30, 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)Population: Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=29 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity])
|
17098.45 h*pg/mL
Interval 15794.52 to 18510.03
|
14210.59 h*pg/mL
Interval 13339.71 to 15138.32
|
PRIMARY outcome
Timeframe: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)Population: Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=29 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Maximum Observed Plasma Concentration (Cmax)
|
1891.30 Picogram per milliliter (pg/mL)
Interval 1741.29 to 2054.24
|
1677.79 Picogram per milliliter (pg/mL)
Interval 1545.53 to 1821.37
|
SECONDARY outcome
Timeframe: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)Population: Pharmacokinetic Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected for the analysis of PK parameters.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Time to Reach Cmax (Tmax)
Day 1
|
2.00 Hour (h)
Interval 0.3 to 3.0
|
2.0 Hour (h)
Interval 0.8 to 5.0
|
|
Cohort 1: Time to Reach Cmax (Tmax)
Day 4
|
1.25 Hour (h)
Interval 0.3 to 5.0
|
1.00 Hour (h)
Interval 0.1 to 3.0
|
|
Cohort 1: Time to Reach Cmax (Tmax)
Day 7
|
1.50 Hour (h)
Interval 0.2 to 4.0
|
1.50 Hour (h)
Interval 0.1 to 4.0
|
|
Cohort 1: Time to Reach Cmax (Tmax)
Day 10
|
1.50 Hour (h)
Interval 0.3 to 5.0
|
1.00 Hour (h)
Interval 0.3 to 4.0
|
SECONDARY outcome
Timeframe: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)Population: Pharmacokinetic Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected for the analysis of PK parameters.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Apparent Terminal Phase Half-life (t1/2)
Day 1
|
7.83 Hour (h)
Standard Deviation 1.093
|
7.50 Hour (h)
Standard Deviation 1.731
|
|
Cohort 1: Apparent Terminal Phase Half-life (t1/2)
Day 4
|
7.62 Hour (h)
Standard Deviation 0.904
|
7.43 Hour (h)
Standard Deviation 1.546
|
|
Cohort 1: Apparent Terminal Phase Half-life (t1/2)
Day 7
|
7.92 Hour (h)
Standard Deviation 2.257
|
7.35 Hour (h)
Standard Deviation 1.388
|
|
Cohort 1: Apparent Terminal Phase Half-life (t1/2)
Day 10
|
8.17 Hour (h)
Standard Deviation 1.377
|
7.22 Hour (h)
Standard Deviation 1.319
|
SECONDARY outcome
Timeframe: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)Population: Pharmacokinetic Population
Blood samples were collected for the analysis of PK parameters.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last])
|
5120.73 h*pg/mL
Interval 4644.42 to 5645.89
|
3977.02 h*pg/mL
Interval 3674.43 to 4304.54
|
SECONDARY outcome
Timeframe: At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)Population: Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected for the analysis of PK parameters.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=29 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=29 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1-Intra-Participant Variability of AUC (0-30min)
|
36.3 Percentage of Coefficient Variation
|
28.7 Percentage of Coefficient Variation
|
SECONDARY outcome
Timeframe: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)Population: Pharmacokinetic Population
Blood samples were collected for the analysis of PK parameters.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Intra Participant Variability of AUC (0-infinity)
|
28.3 Percentage of Coefficient Variation
|
18.6 Percentage of Coefficient Variation
|
SECONDARY outcome
Timeframe: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)Population: Pharmacokinetic Population
Blood samples were collected for the analysis of PK parameters.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Intra Participant Variability of AUC(0-last)
|
28.5 Percentage of Coefficient Variation
|
18.3 Percentage of Coefficient Variation
|
SECONDARY outcome
Timeframe: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)Population: Pharmacokinetic Population
Blood samples were collected for the analysis of PK parameters.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Intra Participant Variability of Cmax
|
33.5 Percentage of Coefficient Variation
|
17.3 Percentage of Coefficient Variation
|
SECONDARY outcome
Timeframe: Up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]Population: Safety Population included all participants who received at least one puff/actuation of study intervention.
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect, abnormal pregnancy outcomes. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AE
|
18 Participants
|
12 Participants
|
|
Cohort 1: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAE
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)Population: Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.
A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the HR and were measured after resting for at least 5 minutes in the supine position.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
Baseline (Pre-dose at Day 1 [Period 1])
|
55.1 Beats per minute
Standard Deviation 6.25
|
52.7 Beats per minute
Standard Deviation 5.14
|
|
Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
Post-dose at 30 minutes on Day 1 [Period 1]
|
63.1 Beats per minute
Standard Deviation 7.02
|
62.6 Beats per minute
Standard Deviation 7.56
|
|
Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
Baseline (Pre-dose at Day 4 [Period 2])
|
53.6 Beats per minute
Standard Deviation 6.32
|
55.0 Beats per minute
Standard Deviation 8.06
|
|
Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
Post-dose at 30 minutes on Day 4 [Period 2]
|
62.3 Beats per minute
Standard Deviation 5.98
|
62.8 Beats per minute
Standard Deviation 5.75
|
|
Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
Baseline (Pre-dose at Day 7 [Period 3])
|
55.4 Beats per minute
Standard Deviation 7.37
|
56.6 Beats per minute
Standard Deviation 6.71
|
|
Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
Post-dose at 30 minutes on Day 7 [Period 3]
|
67.9 Beats per minute
Standard Deviation 9.79
|
62.3 Beats per minute
Standard Deviation 8.68
|
|
Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
Baseline (Pre-dose at Day 10 [Period 4])
|
56.5 Beats per minute
Standard Deviation 6.88
|
53.7 Beats per minute
Standard Deviation 5.03
|
|
Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
Post-dose at 30 minutes on Day 10 [Period 4]
|
64.9 Beats per minute
Standard Deviation 9.31
|
64.2 Beats per minute
Standard Deviation 7.83
|
|
Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
Day 11 (Discharge)
|
60.7 Beats per minute
Standard Deviation 10.59
|
61.2 Beats per minute
Standard Deviation 8.96
|
SECONDARY outcome
Timeframe: Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)Population: Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.
A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the QTcF Interval and were measured after resting for at least 5 minutes in the supine position.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals
Baseline (Pre-dose at Day 1 [Period 1])
|
403.0 milliseconds (ms)
Standard Deviation 16.12
|
411.6 milliseconds (ms)
Standard Deviation 18.70
|
|
Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals
Post-dose at 30 minutes on Day 1 [Period 1]
|
396.4 milliseconds (ms)
Standard Deviation 15.50
|
402.4 milliseconds (ms)
Standard Deviation 16.22
|
|
Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals
Baseline (Pre-dose at Day 4 [Period 2])
|
411.9 milliseconds (ms)
Standard Deviation 18.94
|
399.0 milliseconds (ms)
Standard Deviation 15.77
|
|
Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals
Post-dose at 30 minutes on Day 4 [Period 2]
|
400.4 milliseconds (ms)
Standard Deviation 19.25
|
393.1 milliseconds (ms)
Standard Deviation 16.80
|
|
Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals
Baseline (Pre-dose at Day 7 [Period 3])
|
412.4 milliseconds (ms)
Standard Deviation 18.30
|
397.4 milliseconds (ms)
Standard Deviation 13.64
|
|
Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals
Post-dose at 30 minutes on Day 7 [Period 3]
|
403.6 milliseconds (ms)
Standard Deviation 19.66
|
389.9 milliseconds (ms)
Standard Deviation 12.09
|
|
Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals
Baseline (Pre-dose at Day 10 [Period 4])
|
397.6 milliseconds (ms)
Standard Deviation 13.14
|
411.1 milliseconds (ms)
Standard Deviation 18.06
|
|
Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals
Post-dose at 30 minutes on Day 10 [Period 4]
|
392.7 milliseconds (ms)
Standard Deviation 13.92
|
399.8 milliseconds (ms)
Standard Deviation 21.48
|
|
Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals
Day 11(Discharge)
|
388.9 milliseconds (ms)
Standard Deviation 14.24
|
402.5 milliseconds (ms)
Standard Deviation 19.75
|
SECONDARY outcome
Timeframe: Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)Population: Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.
A standard 12 lead ECG was obtained using an ECG machine that automatically calculated HR and were measured after resting for at least 5 minutes in the supine position.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR
CFB to Post-dose at 30 minutes on Day 4 [Period 2]
|
8.6 Beats per minute
Standard Deviation 3.4
|
7.8 Beats per minute
Standard Deviation 6.43
|
|
Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR
CFB to Post-dose at 30 minutes on Day 7 [Period 3]
|
12.5 Beats per minute
Standard Deviation 7.62
|
5.7 Beats per minute
Standard Deviation 4.84
|
|
Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR
CFB to Post-dose at 30 minutes on Day 10 [Period 4]
|
8.3 Beats per minute
Standard Deviation 5.74
|
10.4 Beats per minute
Standard Deviation 4.79
|
|
Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR
CFB to Day 11 (Discharge)
|
4.1 Beats per minute
Standard Deviation 7.25
|
7.5 Beats per minute
Standard Deviation 6.69
|
|
Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR
CFB to Post-dose at 30 minutes on Day 1 [Period 1]
|
8.0 Beats per minute
Standard Deviation 4.03
|
10.0 Beats per minute
Standard Deviation 3.84
|
SECONDARY outcome
Timeframe: Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)Population: Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.
A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the QTcF Interval and were measured after resting for at least 5 minutes in the supine position.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals
CFB to Post-dose at 30 minutes on Day 1 [Period 1]
|
-6.6 milliseconds (ms)
Standard Deviation 12.78
|
-9.2 milliseconds (ms)
Standard Deviation 6.89
|
|
Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals
CFB to Post-dose at 30 minutes on Day 4 [Period 2]
|
-11.5 milliseconds (ms)
Standard Deviation 4.83
|
-5.9 milliseconds (ms)
Standard Deviation 13.26
|
|
Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals
CFB to Post-dose at 30 minutes on Day 7 [Period 3]
|
-8.9 milliseconds (ms)
Standard Deviation 8.69
|
-7.5 milliseconds (ms)
Standard Deviation 9.04
|
|
Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals
CFB to Post-dose at 30 minutes on Day 10 [Period 4]
|
-4.9 milliseconds (ms)
Standard Deviation 12.68
|
-11.3 milliseconds (ms)
Standard Deviation 8.52
|
|
Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals
CFB to Day 11 (Discharge)
|
-8.7 milliseconds (ms)
Standard Deviation 9.29
|
-8.5 milliseconds (ms)
Standard Deviation 9.99
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 11 (Discharge)Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
Blood samples were collected for analyzing absolute values of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet count. Baseline is defined as the latest non-missing pre-dose value
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=15 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=13 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Neutrophils: Baseline (Day -1)
|
3.62 Giga cells/Liter
Standard Deviation 1.058
|
3.32 Giga cells/Liter
Standard Deviation 1.271
|
|
Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Neutrophils: Day 11 (Discharge)
|
3.05 Giga cells/Liter
Standard Deviation 0.829
|
2.95 Giga cells/Liter
Standard Deviation 0.918
|
|
Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Lymphocytes: Baseline (Day -1)
|
2.07 Giga cells/Liter
Standard Deviation 0.437
|
1.97 Giga cells/Liter
Standard Deviation 0.654
|
|
Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Lymphocytes: Day 11 (Discharge)
|
2.08 Giga cells/Liter
Standard Deviation 0.707
|
1.88 Giga cells/Liter
Standard Deviation 0.472
|
|
Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Monocytes: Baseline (Day -1)
|
0.33 Giga cells/Liter
Standard Deviation 0.062
|
0.33 Giga cells/Liter
Standard Deviation 0.075
|
|
Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Monocytes: Day 11 (Discharge)
|
0.28 Giga cells/Liter
Standard Deviation 0.094
|
0.32 Giga cells/Liter
Standard Deviation 0.080
|
|
Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Eosinophils: Baseline (Day -1)
|
0.13 Giga cells/Liter
Standard Deviation 0.046
|
0.16 Giga cells/Liter
Standard Deviation 0.077
|
|
Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Eosinophils: Day 11 (Discharge)
|
0.11 Giga cells/Liter
Standard Deviation 0.035
|
0.15 Giga cells/Liter
Standard Deviation 0.052
|
|
Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Basophils: Baseline (Day -1)
|
0.03 Giga cells/Liter
Standard Deviation 0.049
|
0.05 Giga cells/Liter
Standard Deviation 0.052
|
|
Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Basophils: Day 11 (Discharge)
|
0.03 Giga cells/Liter
Standard Deviation 0.049
|
0.03 Giga cells/Liter
Standard Deviation 0.048
|
|
Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Platelet count: Baseline (Day -1)
|
254.9 Giga cells/Liter
Standard Deviation 45.61
|
262.8 Giga cells/Liter
Standard Deviation 63.27
|
|
Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Platelet count: Day 11 (Discharge)
|
252.1 Giga cells/Liter
Standard Deviation 40.26
|
230.6 Giga cells/Liter
Standard Deviation 50.04
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 11 (Discharge)Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
Blood samples were collected for analyzing absolute values of Erythrocytes. Baseline is defined as the latest non-missing pre-dose value
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=15 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=13 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Absolute Values of Hematology Parameter: Erythrocytes
Baseline (Day -1)
|
4.890 Trillion cells/Liter
Standard Deviation 0.4431
|
5.158 Trillion cells/Liter
Standard Deviation 0.4141
|
|
Cohort 1: Absolute Values of Hematology Parameter: Erythrocytes
Day 11 (Discharge)
|
4.516 Trillion cells/Liter
Standard Deviation 0.4710
|
4.753 Trillion cells/Liter
Standard Deviation 0.4655
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 11 (Discharge)Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
Blood samples were collected for analyzing absolute values of Mean Corpuscular Volume (MCV). Baseline is defined as the latest non-missing pre-dose value
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=15 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=13 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)
Baseline (Day -1)
|
91.1 femtoliter (fL)
Standard Deviation 4.61
|
92.1 femtoliter (fL)
Standard Deviation 3.04
|
|
Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)
Day 11 (Discharge)
|
90.0 femtoliter (fL)
Standard Deviation 4.26
|
91.6 femtoliter (fL)
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 11 (Discharge)Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
Blood samples were collected for analyzing absolute values of Mean corpuscular hemoglobin (MCH). Baseline is defined as the latest non-missing pre-dose value
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=15 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=13 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Baseline (Day -1)
|
1.817 femtomole (fmol)
Standard Deviation 0.0977
|
1.845 femtomole (fmol)
Standard Deviation 0.0599
|
|
Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Day 11 (Discharge)
|
1.823 femtomole (fmol)
Standard Deviation 0.1077
|
1.841 femtomole (fmol)
Standard Deviation 0.0640
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 11 (Discharge)Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
Blood samples were collected for analyzing absolute values of Hemoglobin. Baseline is defined as the latest non-missing pre-dose value
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=15 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=13 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Absolute Values of Hematology Parameter: Hemoglobin
Baseline (Day -1)
|
143.19 gram per liter (g/L)
Standard Deviation 14.903
|
153.08 gram per liter (g/L)
Standard Deviation 11.699
|
|
Cohort 1: Absolute Values of Hematology Parameter: Hemoglobin
Day 11 (Discharge)
|
132.77 gram per liter (g/L)
Standard Deviation 14.593
|
140.94 gram per liter (g/L)
Standard Deviation 12.026
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 11 (Discharge)Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
Blood samples were collected for analyzing absolute values of Hematocrit. Baseline is defined as the latest non-missing pre-dose value
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=15 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=13 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Absolute Values of Hematology Parameter: Hematocrit
Baseline (Day -1)
|
0.445 Percentage of red blood cells in blood
Standard Deviation 0.0405
|
0.475 Percentage of red blood cells in blood
Standard Deviation 0.0355
|
|
Cohort 1: Absolute Values of Hematology Parameter: Hematocrit
Day 11 (Discharge)
|
0.405 Percentage of red blood cells in blood
Standard Deviation 0.0426
|
0.433 Percentage of red blood cells in blood
Standard Deviation 0.0392
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 11 (Discharge)Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
Blood samples were collected for analyzing absolute values of Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate aminotransferase (AST) and Creatine Phosphokinase (CPK). Baseline is defined as the latest non-missing pre-dose value
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=15 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=13 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
ALT: Baseline (Day -1)
|
21.67 International Units per Liter (IU/L)
Standard Deviation 9.108
|
23.22 International Units per Liter (IU/L)
Standard Deviation 10.178
|
|
Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
ALT: Day 11 (Discharge)
|
19.33 International Units per Liter (IU/L)
Standard Deviation 5.327
|
21.45 International Units per Liter (IU/L)
Standard Deviation 8.102
|
|
Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
ALP: Baseline (Day -1)
|
65.4 International Units per Liter (IU/L)
Standard Deviation 14.26
|
73.1 International Units per Liter (IU/L)
Standard Deviation 17.89
|
|
Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
ALP: Day 11 (Discharge)
|
60.5 International Units per Liter (IU/L)
Standard Deviation 15.85
|
64.4 International Units per Liter (IU/L)
Standard Deviation 12.41
|
|
Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
AST: Baseline (Day -1)
|
12.38 International Units per Liter (IU/L)
Standard Deviation 3.984
|
14.52 International Units per Liter (IU/L)
Standard Deviation 5.611
|
|
Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
AST: Day 11 (Discharge)
|
10.49 International Units per Liter (IU/L)
Standard Deviation 3.010
|
11.66 International Units per Liter (IU/L)
Standard Deviation 4.240
|
|
Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
CPK: Baseline (Day -1)
|
103.1 International Units per Liter (IU/L)
Standard Deviation 44.25
|
120.4 International Units per Liter (IU/L)
Standard Deviation 60.49
|
|
Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
CPK: Day 11 (Discharge)
|
88.1 International Units per Liter (IU/L)
Standard Deviation 61.28
|
79.9 International Units per Liter (IU/L)
Standard Deviation 32.26
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 11 (Discharge)Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
Blood samples were collected for analyzing absolute values of direct bilirubin, total bilirubin, total protein and Creatinine. Baseline is defined as the latest non-missing pre-dose value
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=15 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=13 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine
Direct Bilirubin: Baseline (Day -1)
|
4.12 micromoles per liter (umol/L)
Standard Deviation 2.214
|
4.85 micromoles per liter (umol/L)
Standard Deviation 2.035
|
|
Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine
Direct Bilirubin: Day 11 (Discharge)
|
3.79 micromoles per liter (umol/L)
Standard Deviation 2.055
|
4.15 micromoles per liter (umol/L)
Standard Deviation 1.531
|
|
Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine
Total Bilirubin: Baseline (Day -1)
|
12.2 micromoles per liter (umol/L)
Standard Deviation 6.22
|
16.3 micromoles per liter (umol/L)
Standard Deviation 7.10
|
|
Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine
Total Bilirubin: Day 11 (Discharge)
|
11.8 micromoles per liter (umol/L)
Standard Deviation 5.82
|
13.8 micromoles per liter (umol/L)
Standard Deviation 5.89
|
|
Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine
Total Protein: Baseline (Day -1)
|
74.1 micromoles per liter (umol/L)
Standard Deviation 3.75
|
73.3 micromoles per liter (umol/L)
Standard Deviation 4.19
|
|
Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine
Total Protein: Day 11 (Discharge)
|
68.2 micromoles per liter (umol/L)
Standard Deviation 3.59
|
66.9 micromoles per liter (umol/L)
Standard Deviation 3.40
|
|
Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine
Creatinine: Baseline (Day -1)
|
63.3 micromoles per liter (umol/L)
Standard Deviation 12.48
|
73.6 micromoles per liter (umol/L)
Standard Deviation 18.33
|
|
Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine
Creatinine: Day 11 (Discharge)
|
62.1 micromoles per liter (umol/L)
Standard Deviation 10.92
|
69.4 micromoles per liter (umol/L)
Standard Deviation 15.33
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 11 (Discharge)Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
Blood samples were collected for analyzing absolute values of Calcium, Sodium and Urea Nitrogen. Baseline is defined as the latest non-missing pre-dose value
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=15 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=13 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen
Calcium: Baseline (Day -1)
|
2.388 millimoles per liter (mmol/L)
Standard Deviation 0.0561
|
2.431 millimoles per liter (mmol/L)
Standard Deviation 0.0656
|
|
Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen
Calcium: Day 11 (Discharge)
|
2.300 millimoles per liter (mmol/L)
Standard Deviation 0.0515
|
2.306 millimoles per liter (mmol/L)
Standard Deviation 0.0678
|
|
Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen
Sodium: Baseline (Day -1)
|
139.7 millimoles per liter (mmol/L)
Standard Deviation 2.31
|
139.7 millimoles per liter (mmol/L)
Standard Deviation 1.38
|
|
Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen
Sodium: Day 11 (Discharge)
|
139.7 millimoles per liter (mmol/L)
Standard Deviation 0.90
|
140.3 millimoles per liter (mmol/L)
Standard Deviation 1.03
|
|
Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen
Urea Nitrogen: Baseline (Day -1)
|
4.12 millimoles per liter (mmol/L)
Standard Deviation 0.945
|
4.54 millimoles per liter (mmol/L)
Standard Deviation 1.149
|
|
Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen
Urea Nitrogen: Day 11 (Discharge)
|
4.28 millimoles per liter (mmol/L)
Standard Deviation 0.837
|
4.17 millimoles per liter (mmol/L)
Standard Deviation 0.832
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 1.5, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]Population: Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected for analyzing absolute values of glucose and potassium
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Baseline (Pre-dose at Day 1 [Period 1]), Glucose
|
4.76 millimoles per liter (mmol/L)
Standard Deviation 0.206
|
4.89 millimoles per liter (mmol/L)
Standard Deviation 0.363
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 1: Post-dose at 15 minutes (Period 1), Glucose
|
4.97 millimoles per liter (mmol/L)
Standard Deviation 0.803
|
4.60 millimoles per liter (mmol/L)
Standard Deviation 1.060
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 1: Post-dose at 30 minutes (Period 1), Glucose
|
4.86 millimoles per liter (mmol/L)
Standard Deviation 0.453
|
4.71 millimoles per liter (mmol/L)
Standard Deviation 0.691
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 1: Post-dose at 1 hour (Period 1), Glucose
|
5.20 millimoles per liter (mmol/L)
Standard Deviation 0.716
|
4.92 millimoles per liter (mmol/L)
Standard Deviation 0.415
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 1: Post-dose at 1.5 hours (Period 1), Glucose
|
4.99 millimoles per liter (mmol/L)
Standard Deviation 0.509
|
4.86 millimoles per liter (mmol/L)
Standard Deviation 0.271
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 1: Post-dose at 2 hours (Period 1), Glucose
|
4.77 millimoles per liter (mmol/L)
Standard Deviation 0.322
|
4.72 millimoles per liter (mmol/L)
Standard Deviation 0.356
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 1: Post-dose at 4 hours (Period 1), Glucose
|
4.50 millimoles per liter (mmol/L)
Standard Deviation 0.310
|
4.49 millimoles per liter (mmol/L)
Standard Deviation 0.243
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Baseline (Pre-dose at Day 4 [Period 2]), Glucose
|
4.71 millimoles per liter (mmol/L)
Standard Deviation 0.284
|
4.65 millimoles per liter (mmol/L)
Standard Deviation 0.237
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 4: Post-dose at 15 minutes (Period 2), Glucose
|
4.80 millimoles per liter (mmol/L)
Standard Deviation 0.706
|
4.93 millimoles per liter (mmol/L)
Standard Deviation 0.758
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 4: Post-dose at 30 minutes (Period 2), Glucose
|
4.70 millimoles per liter (mmol/L)
Standard Deviation 0.553
|
4.93 millimoles per liter (mmol/L)
Standard Deviation 0.588
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 4: Post-dose at 1 hour (Period 2), Glucose
|
4.84 millimoles per liter (mmol/L)
Standard Deviation 0.445
|
4.91 millimoles per liter (mmol/L)
Standard Deviation 0.488
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 4: Post-dose at 1.5 hours (Period 2), Glucose
|
4.74 millimoles per liter (mmol/L)
Standard Deviation 0.346
|
4.78 millimoles per liter (mmol/L)
Standard Deviation 0.431
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 4: Post-dose at 2 hours (Period 2), Glucose
|
4.71 millimoles per liter (mmol/L)
Standard Deviation 0.196
|
4.61 millimoles per liter (mmol/L)
Standard Deviation 0.427
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 4: Post-dose at 4 hours (Period 2), Glucose
|
4.57 millimoles per liter (mmol/L)
Standard Deviation 0.258
|
4.53 millimoles per liter (mmol/L)
Standard Deviation 0.355
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Baseline (Pre-dose at Day 7 [Period 3]), Glucose
|
4.63 millimoles per liter (mmol/L)
Standard Deviation 0.307
|
4.59 millimoles per liter (mmol/L)
Standard Deviation 0.232
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 7: Post-dose at 15 minutes (Period 3), Glucose
|
4.66 millimoles per liter (mmol/L)
Standard Deviation 0.852
|
5.02 millimoles per liter (mmol/L)
Standard Deviation 0.895
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 7: Post-dose at 30 minutes (Period 3), Glucose
|
4.56 millimoles per liter (mmol/L)
Standard Deviation 0.577
|
4.88 millimoles per liter (mmol/L)
Standard Deviation 0.680
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 7: Post-dose at 1 hour (Period 3), Glucose
|
4.75 millimoles per liter (mmol/L)
Standard Deviation 0.320
|
4.68 millimoles per liter (mmol/L)
Standard Deviation 0.449
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 7: Post-dose at 1.5 hours (Period 3), Glucose
|
4.76 millimoles per liter (mmol/L)
Standard Deviation 0.414
|
4.72 millimoles per liter (mmol/L)
Standard Deviation 0.369
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 7: Post-dose at 2 hours (Period 3), Glucose
|
4.57 millimoles per liter (mmol/L)
Standard Deviation 0.358
|
4.49 millimoles per liter (mmol/L)
Standard Deviation 0.286
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 7: Post-dose at 4 hours (Period 3), Glucose
|
4.51 millimoles per liter (mmol/L)
Standard Deviation 0.236
|
4.51 millimoles per liter (mmol/L)
Standard Deviation 0.299
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Baseline (Pre-dose at Day 10 (Period 4), Glucose
|
4.62 millimoles per liter (mmol/L)
Standard Deviation 0.283
|
4.66 millimoles per liter (mmol/L)
Standard Deviation 0.166
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 10: Post-dose at 15 minutes (Period 4), Glucose
|
4.97 millimoles per liter (mmol/L)
Standard Deviation 0.701
|
4.99 millimoles per liter (mmol/L)
Standard Deviation 0.856
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 10: Post-dose at 30 minutes (Period 4), Glucose
|
4.90 millimoles per liter (mmol/L)
Standard Deviation 0.650
|
4.98 millimoles per liter (mmol/L)
Standard Deviation 0.938
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 10: Post-dose at 1 hour (Period 4), Glucose
|
5.01 millimoles per liter (mmol/L)
Standard Deviation 0.476
|
4.92 millimoles per liter (mmol/L)
Standard Deviation 0.518
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 10: Post-dose at 1.5 hours (Period 4), Glucose
|
4.60 millimoles per liter (mmol/L)
Standard Deviation 0.280
|
4.86 millimoles per liter (mmol/L)
Standard Deviation 0.548
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 10: Post-dose at 2 hours (Period 4), Glucose
|
4.47 millimoles per liter (mmol/L)
Standard Deviation 0.246
|
4.59 millimoles per liter (mmol/L)
Standard Deviation 0.278
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 10: Post-dose at 4 hours (Period 4), Glucose
|
4.55 millimoles per liter (mmol/L)
Standard Deviation 0.304
|
4.48 millimoles per liter (mmol/L)
Standard Deviation 0.239
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Baseline (Pre-dose at Day 1 [Period 1]), Potassium
|
4.19 millimoles per liter (mmol/L)
Standard Deviation 0.208
|
4.37 millimoles per liter (mmol/L)
Standard Deviation 0.289
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 1: Post-dose at 15 minutes (Period 1), Potassium
|
4.18 millimoles per liter (mmol/L)
Standard Deviation 0.261
|
4.29 millimoles per liter (mmol/L)
Standard Deviation 0.244
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 1: Post-dose at 30 minutes (Period 1), Potassium
|
4.21 millimoles per liter (mmol/L)
Standard Deviation 0.342
|
4.35 millimoles per liter (mmol/L)
Standard Deviation 0.241
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 1: Post-dose at 1 hour (Period 1), Potassium
|
4.16 millimoles per liter (mmol/L)
Standard Deviation 0.175
|
4.24 millimoles per liter (mmol/L)
Standard Deviation 0.191
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 1: Post-dose at 1.5 hours (Period 1), Potassium
|
4.21 millimoles per liter (mmol/L)
Standard Deviation 0.188
|
4.49 millimoles per liter (mmol/L)
Standard Deviation 0.487
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 1: Post-dose at 2 hours (Period 1), Potassium
|
4.20 millimoles per liter (mmol/L)
Standard Deviation 0.219
|
4.21 millimoles per liter (mmol/L)
Standard Deviation 0.144
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 1: Post-dose at 4 hours (Period 1), Potassium
|
4.13 millimoles per liter (mmol/L)
Standard Deviation 0.268
|
4.28 millimoles per liter (mmol/L)
Standard Deviation 0.255
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Baseline (Pre-dose at Day 4 [Period 2]), Potassium
|
4.33 millimoles per liter (mmol/L)
Standard Deviation 0.367
|
4.46 millimoles per liter (mmol/L)
Standard Deviation 0.301
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 4: Post-dose at 15 minutes (Period 2), Potassium
|
4.47 millimoles per liter (mmol/L)
Standard Deviation 0.307
|
4.21 millimoles per liter (mmol/L)
Standard Deviation 0.359
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 4: Post-dose at 30 minutes (Period 2), Potassium
|
4.27 millimoles per liter (mmol/L)
Standard Deviation 0.205
|
4.37 millimoles per liter (mmol/L)
Standard Deviation 0.793
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 4: Post-dose at 1 hour (Period 2), Potassium
|
4.27 millimoles per liter (mmol/L)
Standard Deviation 0.194
|
4.25 millimoles per liter (mmol/L)
Standard Deviation 0.264
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 4: Post-dose at 1.5 hours (Period 2), Potassium
|
4.20 millimoles per liter (mmol/L)
Standard Deviation 0.196
|
4.24 millimoles per liter (mmol/L)
Standard Deviation 0.175
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 4: Post-dose at 2 hours (Period 2), Potassium
|
4.19 millimoles per liter (mmol/L)
Standard Deviation 0.188
|
4.24 millimoles per liter (mmol/L)
Standard Deviation 0.213
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 4: Post-dose at 4 hours (Period 2), Potassium
|
4.12 millimoles per liter (mmol/L)
Standard Deviation 0.167
|
4.26 millimoles per liter (mmol/L)
Standard Deviation 0.253
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Baseline (Pre-dose at Day 7 [Period 3]), Potassium
|
4.41 millimoles per liter (mmol/L)
Standard Deviation 0.337
|
4.35 millimoles per liter (mmol/L)
Standard Deviation 0.228
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 7: Post-dose at 15 minutes (Period 3), Potassium
|
4.18 millimoles per liter (mmol/L)
Standard Deviation 0.268
|
4.24 millimoles per liter (mmol/L)
Standard Deviation 0.294
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 7: Post-dose at 30 minutes (Period 3), Potassium
|
4.20 millimoles per liter (mmol/L)
Standard Deviation 0.255
|
4.32 millimoles per liter (mmol/L)
Standard Deviation 0.256
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 7: Post-dose at 1 hour (Period 3), Potassium
|
4.18 millimoles per liter (mmol/L)
Standard Deviation 0.125
|
4.16 millimoles per liter (mmol/L)
Standard Deviation 0.163
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 7: Post-dose at 1.5 hours (Period 3), Potassium
|
4.26 millimoles per liter (mmol/L)
Standard Deviation 0.247
|
4.26 millimoles per liter (mmol/L)
Standard Deviation 0.328
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 7: Post-dose at 2 hours (Period 3), Potassium
|
4.12 millimoles per liter (mmol/L)
Standard Deviation 0.119
|
4.26 millimoles per liter (mmol/L)
Standard Deviation 0.258
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 7: Post-dose at 4 hours (Period 3), Potassium
|
4.12 millimoles per liter (mmol/L)
Standard Deviation 0.300
|
4.25 millimoles per liter (mmol/L)
Standard Deviation 0.327
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Baseline (Pre-dose at Day 10 (Period 4), Potassium
|
4.25 millimoles per liter (mmol/L)
Standard Deviation 0.239
|
4.35 millimoles per liter (mmol/L)
Standard Deviation 0.282
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 10: Post-dose at 15 minutes (Period 4), Potassium
|
4.17 millimoles per liter (mmol/L)
Standard Deviation 0.167
|
4.16 millimoles per liter (mmol/L)
Standard Deviation 0.185
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 10: Post-dose at 30 minutes (Period 4), Potassium
|
4.21 millimoles per liter (mmol/L)
Standard Deviation 0.327
|
4.26 millimoles per liter (mmol/L)
Standard Deviation 0.214
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 10: Post-dose at 1 hour (Period 4), Potassium
|
4.22 millimoles per liter (mmol/L)
Standard Deviation 0.258
|
4.15 millimoles per liter (mmol/L)
Standard Deviation 0.133
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 10: Post-dose at 1.5 hours (Period 4), Potassium
|
4.19 millimoles per liter (mmol/L)
Standard Deviation 0.233
|
4.13 millimoles per liter (mmol/L)
Standard Deviation 0.144
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 10: Post-dose at 2 hours (Period 4), Potassium
|
4.15 millimoles per liter (mmol/L)
Standard Deviation 0.200
|
4.13 millimoles per liter (mmol/L)
Standard Deviation 0.149
|
|
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 10: Post-dose at 4 hours (Period 4), Potassium
|
4.13 millimoles per liter (mmol/L)
Standard Deviation 0.167
|
4.12 millimoles per liter (mmol/L)
Standard Deviation 0.141
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]Population: Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.
SBP and DBP measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Manual techniques were used only if an automated device was not available.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Baseline (Pre-dose at Day 1 [Period 1]), SBP
|
108.6 millimeters of mercury (mmHg)
Standard Deviation 6.83
|
111.9 millimeters of mercury (mmHg)
Standard Deviation 7.24
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 1: Post-dose at 15 minutes (Period 1), SBP
|
109.9 millimeters of mercury (mmHg)
Standard Deviation 10.19
|
113.9 millimeters of mercury (mmHg)
Standard Deviation 4.83
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 1: Post-dose at 30 minutes (Period 1), SBP
|
112.2 millimeters of mercury (mmHg)
Standard Deviation 8.84
|
115.9 millimeters of mercury (mmHg)
Standard Deviation 6.54
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 1: Post-dose at 1 hour (Period 1), SBP
|
107.9 millimeters of mercury (mmHg)
Standard Deviation 11.74
|
112.6 millimeters of mercury (mmHg)
Standard Deviation 7.75
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 1: Post-dose at 2 hours (Period 1), SBP
|
107.9 millimeters of mercury (mmHg)
Standard Deviation 9.39
|
107.6 millimeters of mercury (mmHg)
Standard Deviation 6.55
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 1: Post-dose at 4 hours (Period 1), SBP
|
106.8 millimeters of mercury (mmHg)
Standard Deviation 9.02
|
109.1 millimeters of mercury (mmHg)
Standard Deviation 7.92
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Baseline (Pre-dose at Day 4 [Period 2]), SBP
|
110.2 millimeters of mercury (mmHg)
Standard Deviation 10.16
|
104.9 millimeters of mercury (mmHg)
Standard Deviation 8.99
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 4: Post-dose at 15 minutes (Period 2), SBP
|
113.6 millimeters of mercury (mmHg)
Standard Deviation 7.52
|
108.3 millimeters of mercury (mmHg)
Standard Deviation 8.12
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 4: Post-dose at 30 minutes (Period 2), SBP
|
113.9 millimeters of mercury (mmHg)
Standard Deviation 7.53
|
112.1 millimeters of mercury (mmHg)
Standard Deviation 11.79
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 4: Post-dose at 1 hour (Period 2), SBP
|
113.0 millimeters of mercury (mmHg)
Standard Deviation 9.99
|
107.5 millimeters of mercury (mmHg)
Standard Deviation 7.69
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 4: Post-dose at 2 hours (Period 2), SBP
|
110.4 millimeters of mercury (mmHg)
Standard Deviation 11.66
|
104.5 millimeters of mercury (mmHg)
Standard Deviation 8.93
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 4: Post-dose at 4 hours (Period 2), SBP
|
109.3 millimeters of mercury (mmHg)
Standard Deviation 9.00
|
104.3 millimeters of mercury (mmHg)
Standard Deviation 9.29
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Baseline (Pre-dose at Day 7 [Period 3]), SBP
|
110.3 millimeters of mercury (mmHg)
Standard Deviation 8.09
|
103.3 millimeters of mercury (mmHg)
Standard Deviation 9.75
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 7: Post-dose at 15 minutes (Period 3), SBP
|
111.8 millimeters of mercury (mmHg)
Standard Deviation 6.29
|
106.4 millimeters of mercury (mmHg)
Standard Deviation 8.63
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 7: Post-dose at 30 minutes (Period 3), SBP
|
116.4 millimeters of mercury (mmHg)
Standard Deviation 7.55
|
108.6 millimeters of mercury (mmHg)
Standard Deviation 10.65
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 7: Post-dose at 1 hour (Period 3), SBP
|
113.2 millimeters of mercury (mmHg)
Standard Deviation 7.16
|
104.3 millimeters of mercury (mmHg)
Standard Deviation 7.67
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 7: Post-dose at 2 hours (Period 3), SBP
|
107.4 millimeters of mercury (mmHg)
Standard Deviation 8.38
|
102.4 millimeters of mercury (mmHg)
Standard Deviation 9.85
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 7: Post-dose at 4 hours (Period 3), SBP
|
110.5 millimeters of mercury (mmHg)
Standard Deviation 7.89
|
102.3 millimeters of mercury (mmHg)
Standard Deviation 9.26
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Baseline (Pre-dose at Day 10 (Period 4), SBP
|
108.0 millimeters of mercury (mmHg)
Standard Deviation 9.06
|
111.2 millimeters of mercury (mmHg)
Standard Deviation 5.20
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 10: Post-dose at 15 minutes (Period 4), SBP
|
107.1 millimeters of mercury (mmHg)
Standard Deviation 9.63
|
114.2 millimeters of mercury (mmHg)
Standard Deviation 10.43
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 10: Post-dose at 30 minutes (Period 4), SBP
|
109.1 millimeters of mercury (mmHg)
Standard Deviation 9.93
|
115.2 millimeters of mercury (mmHg)
Standard Deviation 8.41
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 10: Post-dose at 1 hour (Period 4), SBP
|
106.7 millimeters of mercury (mmHg)
Standard Deviation 10.72
|
112.6 millimeters of mercury (mmHg)
Standard Deviation 7.31
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 10: Post-dose at 2 hours (Period 4), SBP
|
104.5 millimeters of mercury (mmHg)
Standard Deviation 7.36
|
106.1 millimeters of mercury (mmHg)
Standard Deviation 7.03
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 10: Post-dose at 4 hours (Period 4), SBP
|
105.1 millimeters of mercury (mmHg)
Standard Deviation 12.34
|
110.3 millimeters of mercury (mmHg)
Standard Deviation 6.45
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Baseline (Pre-dose at Day 1 [Period 1]), DBP
|
65.6 millimeters of mercury (mmHg)
Standard Deviation 4.47
|
67.8 millimeters of mercury (mmHg)
Standard Deviation 6.81
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 1: Post-dose at 15 minutes (Period 1), DBP
|
62.7 millimeters of mercury (mmHg)
Standard Deviation 6.19
|
66.0 millimeters of mercury (mmHg)
Standard Deviation 3.84
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 1: Post-dose at 30 minutes (Period 1), DBP
|
65.5 millimeters of mercury (mmHg)
Standard Deviation 5.32
|
66.4 millimeters of mercury (mmHg)
Standard Deviation 5.02
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 1: Post-dose at 1 hour (Period 1), DBP
|
62.7 millimeters of mercury (mmHg)
Standard Deviation 5.56
|
63.0 millimeters of mercury (mmHg)
Standard Deviation 5.66
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 1: Post-dose at 2 hours (Period 1), DBP
|
63.4 millimeters of mercury (mmHg)
Standard Deviation 4.84
|
63.5 millimeters of mercury (mmHg)
Standard Deviation 4.90
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 1: Post-dose at 4 hours (Period 1), DBP
|
63.3 millimeters of mercury (mmHg)
Standard Deviation 5.35
|
63.4 millimeters of mercury (mmHg)
Standard Deviation 5.29
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Baseline (Pre-dose at Day 4 [Period 2]), DBP
|
64.1 millimeters of mercury (mmHg)
Standard Deviation 4.24
|
65.3 millimeters of mercury (mmHg)
Standard Deviation 5.74
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 4: Post-dose at 15 minutes (Period 2), DBP
|
64.9 millimeters of mercury (mmHg)
Standard Deviation 4.14
|
63.9 millimeters of mercury (mmHg)
Standard Deviation 6.46
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 4: Post-dose at 30 minutes (Period 2), DBP
|
63.9 millimeters of mercury (mmHg)
Standard Deviation 4.51
|
64.8 millimeters of mercury (mmHg)
Standard Deviation 7.33
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 4: Post-dose at 1 hour (Period 2), DBP
|
62.1 millimeters of mercury (mmHg)
Standard Deviation 5.46
|
63.8 millimeters of mercury (mmHg)
Standard Deviation 6.38
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 4: Post-dose at 2 hours (Period 2), DBP
|
63.3 millimeters of mercury (mmHg)
Standard Deviation 6.09
|
63.3 millimeters of mercury (mmHg)
Standard Deviation 5.99
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 4: Post-dose at 4 hours (Period 2), DBP
|
61.4 millimeters of mercury (mmHg)
Standard Deviation 5.02
|
62.9 millimeters of mercury (mmHg)
Standard Deviation 4.24
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Baseline (Pre-dose at Day 7 [Period 3]), DBP
|
68.1 millimeters of mercury (mmHg)
Standard Deviation 4.91
|
65.0 millimeters of mercury (mmHg)
Standard Deviation 4.38
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 7: Post-dose at 15 minutes (Period 3), DBP
|
63.6 millimeters of mercury (mmHg)
Standard Deviation 5.53
|
60.7 millimeters of mercury (mmHg)
Standard Deviation 5.19
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 7: Post-dose at 30 minutes (Period 3), DBP
|
64.7 millimeters of mercury (mmHg)
Standard Deviation 4.91
|
62.3 millimeters of mercury (mmHg)
Standard Deviation 4.58
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 7: Post-dose at 1 hour (Period 3), DBP
|
64.4 millimeters of mercury (mmHg)
Standard Deviation 4.94
|
60.9 millimeters of mercury (mmHg)
Standard Deviation 5.14
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 7: Post-dose at 2 hours (Period 3), DBP
|
60.7 millimeters of mercury (mmHg)
Standard Deviation 5.22
|
62.3 millimeters of mercury (mmHg)
Standard Deviation 6.25
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 7: Post-dose at 4 hours (Period 3), DBP
|
63.9 millimeters of mercury (mmHg)
Standard Deviation 4.75
|
61.6 millimeters of mercury (mmHg)
Standard Deviation 7.35
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Baseline (Pre-dose at Day 10 (Period 4), DBP
|
66.1 millimeters of mercury (mmHg)
Standard Deviation 6.46
|
65.1 millimeters of mercury (mmHg)
Standard Deviation 3.99
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 10: Post-dose at 15 minutes (Period 4), DBP
|
63.4 millimeters of mercury (mmHg)
Standard Deviation 5.44
|
64.6 millimeters of mercury (mmHg)
Standard Deviation 6.36
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 10: Post-dose at 30 minutes (Period 4), DBP
|
62.9 millimeters of mercury (mmHg)
Standard Deviation 5.19
|
66.5 millimeters of mercury (mmHg)
Standard Deviation 6.70
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 10: Post-dose at 1 hour (Period 4), DBP
|
63.4 millimeters of mercury (mmHg)
Standard Deviation 5.85
|
62.0 millimeters of mercury (mmHg)
Standard Deviation 4.16
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 10: Post-dose at 2 hours (Period 4), DBP
|
62.5 millimeters of mercury (mmHg)
Standard Deviation 5.97
|
62.8 millimeters of mercury (mmHg)
Standard Deviation 4.93
|
|
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 10: Post-dose at 4 hours (Period 4), DBP
|
63.2 millimeters of mercury (mmHg)
Standard Deviation 8.79
|
63.0 millimeters of mercury (mmHg)
Standard Deviation 3.92
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]Population: Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.
Pulse rate measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Manual techniques were used only if an automated device was not available.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 1: Absolute Values of Pulse Rate (PR)
Day 7: Post-dose at 30 minutes (Period 3)
|
65.3 Beats per minute
Standard Deviation 7.43
|
62.6 Beats per minute
Standard Deviation 8.41
|
|
Cohort 1: Absolute Values of Pulse Rate (PR)
Day 7: Post-dose at 1 hour (Period 3)
|
63.6 Beats per minute
Standard Deviation 7.62
|
61.6 Beats per minute
Standard Deviation 6.73
|
|
Cohort 1: Absolute Values of Pulse Rate (PR)
Day 7: Post-dose at 2 hours (Period 3)
|
59.0 Beats per minute
Standard Deviation 5.80
|
57.5 Beats per minute
Standard Deviation 7.84
|
|
Cohort 1: Absolute Values of Pulse Rate (PR)
Baseline (Pre-dose at Day 1 [Period 1])
|
55.7 Beats per minute
Standard Deviation 7.07
|
51.1 Beats per minute
Standard Deviation 6.27
|
|
Cohort 1: Absolute Values of Pulse Rate (PR)
Day 1: Post-dose at 15 minutes (Period 1)
|
63.9 Beats per minute
Standard Deviation 8.07
|
65.3 Beats per minute
Standard Deviation 9.14
|
|
Cohort 1: Absolute Values of Pulse Rate (PR)
Day 1: Post-dose at 30 minutes (Period 1)
|
61.9 Beats per minute
Standard Deviation 7.02
|
63.6 Beats per minute
Standard Deviation 10.03
|
|
Cohort 1: Absolute Values of Pulse Rate (PR)
Day 1: Post-dose at 1 hour (Period 1)
|
60.0 Beats per minute
Standard Deviation 7.87
|
58.7 Beats per minute
Standard Deviation 7.25
|
|
Cohort 1: Absolute Values of Pulse Rate (PR)
Day 1: Post-dose at 2 hours (Period 1)
|
57.7 Beats per minute
Standard Deviation 9.17
|
54.9 Beats per minute
Standard Deviation 6.79
|
|
Cohort 1: Absolute Values of Pulse Rate (PR)
Day 1: Post-dose at 4 hours (Period 1)
|
55.8 Beats per minute
Standard Deviation 7.25
|
53.6 Beats per minute
Standard Deviation 6.25
|
|
Cohort 1: Absolute Values of Pulse Rate (PR)
Baseline (Pre-dose at Day 4 [Period 2])
|
52.7 Beats per minute
Standard Deviation 7.17
|
54.4 Beats per minute
Standard Deviation 8.55
|
|
Cohort 1: Absolute Values of Pulse Rate (PR)
Day 4: Post-dose at 15 minutes (Period 2)
|
64.7 Beats per minute
Standard Deviation 5.31
|
65.3 Beats per minute
Standard Deviation 6.87
|
|
Cohort 1: Absolute Values of Pulse Rate (PR)
Day 4: Post-dose at 30 minutes (Period 2)
|
62.8 Beats per minute
Standard Deviation 6.60
|
64.1 Beats per minute
Standard Deviation 4.44
|
|
Cohort 1: Absolute Values of Pulse Rate (PR)
Day 4: Post-dose at 1 hour (Period 2)
|
62.1 Beats per minute
Standard Deviation 7.24
|
59.3 Beats per minute
Standard Deviation 7.11
|
|
Cohort 1: Absolute Values of Pulse Rate (PR)
Day 4: Post-dose at 2 hours (Period 2)
|
57.1 Beats per minute
Standard Deviation 5.20
|
56.8 Beats per minute
Standard Deviation 8.64
|
|
Cohort 1: Absolute Values of Pulse Rate (PR)
Day 4: Post-dose at 4 hours (Period 2)
|
57.1 Beats per minute
Standard Deviation 6.41
|
57.9 Beats per minute
Standard Deviation 10.99
|
|
Cohort 1: Absolute Values of Pulse Rate (PR)
Baseline (Pre-dose at Day 7 [Period 3])
|
54.7 Beats per minute
Standard Deviation 7.34
|
56.8 Beats per minute
Standard Deviation 6.01
|
|
Cohort 1: Absolute Values of Pulse Rate (PR)
Day 7: Post-dose at 15 minutes (Period 3)
|
69.2 Beats per minute
Standard Deviation 10.98
|
65.6 Beats per minute
Standard Deviation 9.18
|
|
Cohort 1: Absolute Values of Pulse Rate (PR)
Day 7: Post-dose at 4 hours (Period 3)
|
59.8 Beats per minute
Standard Deviation 5.74
|
57.6 Beats per minute
Standard Deviation 9.26
|
|
Cohort 1: Absolute Values of Pulse Rate (PR)
Baseline (Pre-dose at Day 10 (Period 4)
|
55.6 Beats per minute
Standard Deviation 8.56
|
54.5 Beats per minute
Standard Deviation 5.61
|
|
Cohort 1: Absolute Values of Pulse Rate (PR)
Day 10: Post-dose at 15 minutes (Period 4)
|
67.5 Beats per minute
Standard Deviation 7.24
|
68.0 Beats per minute
Standard Deviation 9.70
|
|
Cohort 1: Absolute Values of Pulse Rate (PR)
Day 10: Post-dose at 30 minutes (Period 4)
|
65.3 Beats per minute
Standard Deviation 9.80
|
63.4 Beats per minute
Standard Deviation 7.98
|
|
Cohort 1: Absolute Values of Pulse Rate (PR)
Day 10: Post-dose at 1 hour (Period 4)
|
63.7 Beats per minute
Standard Deviation 7.82
|
62.1 Beats per minute
Standard Deviation 9.12
|
|
Cohort 1: Absolute Values of Pulse Rate (PR)
Day 10: Post-dose at 2 hours (Period 4)
|
58.1 Beats per minute
Standard Deviation 6.92
|
58.9 Beats per minute
Standard Deviation 8.41
|
|
Cohort 1: Absolute Values of Pulse Rate (PR)
Day 10: Post-dose at 4 hours (Period 4)
|
58.6 Beats per minute
Standard Deviation 7.81
|
56.8 Beats per minute
Standard Deviation 7.51
|
SECONDARY outcome
Timeframe: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 [ Period 3] and Day 10 [Period 4]Population: Pharmacokinetic Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected for the analysis of PK parameters.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Time to Reach Cmax (Tmax)
Day 10
|
1.50 Hour
Interval 0.3 to 6.0
|
1.50 Hour
Interval 0.1 to 4.0
|
|
Cohort 2: Time to Reach Cmax (Tmax)
Day 1
|
1.50 Hour
Interval 0.2 to 4.0
|
1.25 Hour
Interval 0.3 to 2.0
|
|
Cohort 2: Time to Reach Cmax (Tmax)
Day 4
|
1.50 Hour
Interval 0.5 to 4.0
|
1.50 Hour
Interval 0.3 to 5.0
|
|
Cohort 2: Time to Reach Cmax (Tmax)
Day 7
|
1.50 Hour
Interval 0.2 to 5.0
|
1.50 Hour
Interval 0.3 to 4.0
|
SECONDARY outcome
Timeframe: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)Population: Pharmacokinetic Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected for the analysis of PK parameters.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Apparent Terminal Phase Half-life (t1/2)
Day 1
|
8.56 Hour
Standard Deviation 1.945
|
7.73 Hour
Standard Deviation 1.162
|
|
Cohort 2: Apparent Terminal Phase Half-life (t1/2)
Day 4
|
7.65 Hour
Standard Deviation 1.022
|
7.79 Hour
Standard Deviation 1.380
|
|
Cohort 2: Apparent Terminal Phase Half-life (t1/2)
Day 7
|
7.61 Hour
Standard Deviation 1.247
|
7.57 Hour
Standard Deviation 1.438
|
|
Cohort 2: Apparent Terminal Phase Half-life (t1/2)
Day 10
|
7.87 Hour
Standard Deviation 1.678
|
7.74 Hour
Standard Deviation 1.613
|
SECONDARY outcome
Timeframe: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)Population: Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected for the analysis of PK parameters.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=29 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last])
|
15345.11 h*pg/mL
Interval 14137.58 to 16655.78
|
12840.80 h*pg/mL
Interval 12011.17 to 13727.73
|
SECONDARY outcome
Timeframe: At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)Population: Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected for the analysis of PK parameters.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=29 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2-Intra-Participant Variability of AUC (0-30min)
|
22.9 Percentage of Coefficient Variation
|
25.8 Percentage of Coefficient Variation
|
SECONDARY outcome
Timeframe: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)Population: Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected for the analysis of PK parameters.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=29 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Intra Participant Variability of AUC (0-infinity)
|
10.0 Percentage of Coefficient Variation
|
8.6 Percentage of Coefficient Variation
|
SECONDARY outcome
Timeframe: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)Population: Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected for the analysis of PK parameters.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=29 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Intra Participant Variability of AUC (0-last)
|
10.4 Percentage of Coefficient Variation
|
9.0 Percentage of Coefficient Variation
|
SECONDARY outcome
Timeframe: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)Population: Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected for the analysis of PK parameters.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=29 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Intra Participant Variability of Cmax
|
14.1 Percentage of Coefficient Variation
|
12.2 Percentage of Coefficient Variation
|
SECONDARY outcome
Timeframe: Up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]Population: Safety Population included all participants who received at least one puff/actuation of study intervention.
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect, abnormal pregnancy outcomes. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AE
|
20 Participants
|
21 Participants
|
|
Cohort 2: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAE
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)Population: Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.
A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the HR and were measured after resting for at least 5 minutes in the supine position.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
Baseline (Pre-dose at Day 1 [Period 1])
|
63.9 Beats per minute
Standard Deviation 13.10
|
53.2 Beats per minute
Standard Deviation 7.91
|
|
Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
Post-dose at 30 minutes on Day 1 (Period 1)
|
75.9 Beats per minute
Standard Deviation 14.29
|
66.4 Beats per minute
Standard Deviation 7.27
|
|
Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
Baseline (Pre-dose at Day 4 [Period 2])
|
54.5 Beats per minute
Standard Deviation 7.76
|
61.4 Beats per minute
Standard Deviation 9.38
|
|
Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
Post-dose at 30 minutes on Day 4 (Period 2)
|
66.7 Beats per minute
Standard Deviation 8.67
|
76.4 Beats per minute
Standard Deviation 13.83
|
|
Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
Baseline (Pre-dose at Day 7 [Period 3])
|
55.1 Beats per minute
Standard Deviation 8.38
|
64.1 Beats per minute
Standard Deviation 10.77
|
|
Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
Post-dose at 30 minutes on Day 7 (Period 3)
|
66.7 Beats per minute
Standard Deviation 8.65
|
75.2 Beats per minute
Standard Deviation 10.17
|
|
Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
Baseline (Pre-dose at Day 10 [Period 4])
|
64.1 Beats per minute
Standard Deviation 9.09
|
55.4 Beats per minute
Standard Deviation 8.04
|
|
Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
Post-dose at 30 minutes on Day 10 (Period 4)
|
77.1 Beats per minute
Standard Deviation 11.11
|
68.4 Beats per minute
Standard Deviation 9.49
|
|
Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
Day 11 (Discharge)
|
67.8 Beats per minute
Standard Deviation 10.68
|
59.4 Beats per minute
Standard Deviation 10.65
|
SECONDARY outcome
Timeframe: Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)Population: Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.
A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the QTcF Interval and were measured after resting for at least 5 minutes in the supine position.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals
Post-dose at 30 minutes on Day 4 (Period 2)
|
399.6 milliseconds (ms)
Standard Deviation 23.18
|
401.9 milliseconds (ms)
Standard Deviation 19.28
|
|
Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals
Baseline (Pre-dose at Day 7 [Period 3])
|
399.9 milliseconds (ms)
Standard Deviation 24.76
|
402.7 milliseconds (ms)
Standard Deviation 17.59
|
|
Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals
Post-dose at 30 minutes on Day 7 (Period 3)
|
402.5 milliseconds (ms)
Standard Deviation 23.59
|
407.8 milliseconds (ms)
Standard Deviation 24.84
|
|
Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals
Baseline (Pre-dose at Day 10 [Period 4])
|
401.8 milliseconds (ms)
Standard Deviation 15.07
|
397.7 milliseconds (ms)
Standard Deviation 22.86
|
|
Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals
Post-dose at 30 minutes on Day 10 (Period 4)
|
400.2 milliseconds (ms)
Standard Deviation 12.76
|
400.6 milliseconds (ms)
Standard Deviation 22.53
|
|
Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals
Day 11 (Discharge)
|
395.9 milliseconds (ms)
Standard Deviation 18.19
|
391.2 milliseconds (ms)
Standard Deviation 22.25
|
|
Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals
Post-dose at 30 minutes on Day 1 (Period 1)
|
400.8 milliseconds (ms)
Standard Deviation 17.71
|
402.9 milliseconds (ms)
Standard Deviation 18.43
|
|
Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals
Baseline (Pre-dose at Day 4 [Period 2])
|
398.9 milliseconds (ms)
Standard Deviation 25.14
|
401.9 milliseconds (ms)
Standard Deviation 17.55
|
|
Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals
Baseline (Pre-dose at Day 1 [Period 1])
|
407.8 milliseconds (ms)
Standard Deviation 17.31
|
399.9 milliseconds (ms)
Standard Deviation 21.05
|
SECONDARY outcome
Timeframe: Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)Population: Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.
A standard 12 lead ECG was obtained using an ECG machine that automatically calculated HR and were measured after resting for at least 5 minutes in the supine position.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR
CFB to Post-dose at 30 minutes on Day 1 [Period 1]
|
12.0 Beats per minute
Standard Deviation 8.45
|
13.2 Beats per minute
Standard Deviation 4.51
|
|
Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR
CFB to Post-dose at 30 minutes on Day 4 [Period 2]
|
12.2 Beats per minute
Standard Deviation 4.99
|
15.0 Beats per minute
Standard Deviation 9.10
|
|
Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR
CFB to Post-dose at 30 minutes on Day 7 [Period 3]
|
11.6 Beats per minute
Standard Deviation 4.52
|
11.1 Beats per minute
Standard Deviation 4.51
|
|
Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR
CFB to Post-dose at 30 minutes on Day 10 [Period 4]
|
12.9 Beats per minute
Standard Deviation 7.17
|
13.0 Beats per minute
Standard Deviation 6.31
|
|
Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR
CFB to Day 11 (Discharge)
|
3.7 Beats per minute
Standard Deviation 5.21
|
4.0 Beats per minute
Standard Deviation 4.81
|
SECONDARY outcome
Timeframe: Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)Population: Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.
A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the QTcF Interval and were measured after resting for at least 5 minutes in the supine position.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals
CFB to Post-dose at 30 minutes on Day 1 [Period 1]
|
-7.0 milliseconds
Standard Deviation 6.96
|
3.0 milliseconds
Standard Deviation 10.59
|
|
Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals
CFB to Post-dose at 30 minutes on Day 4 [Period 2]
|
0.7 milliseconds
Standard Deviation 9.87
|
0.0 milliseconds
Standard Deviation 14.23
|
|
Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals
CFB to Post-dose at 30 minutes on Day 7 [Period 3]
|
2.6 milliseconds
Standard Deviation 11.18
|
5.1 milliseconds
Standard Deviation 16.88
|
|
Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals
CFB to Post-dose at 30 minutes on Day 10 [Period 4]
|
-1.7 milliseconds
Standard Deviation 5.52
|
2.9 milliseconds
Standard Deviation 8.88
|
|
Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals
CFB to Day 11 (Discharge)
|
-5.9 milliseconds
Standard Deviation 9.40
|
-6.5 milliseconds
Standard Deviation 8.79
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 11 (Discharge)Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
Blood samples were collected for analyzing absolute values of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet count. Baseline is defined as the latest non-missing pre-dose value
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=13 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=16 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Monocytes: Day 11 (Discharge)
|
0.34 Giga cells/Liter
Standard Deviation 0.096
|
0.33 Giga cells/Liter
Standard Deviation 0.095
|
|
Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Basophils: Baseline (Day -1)
|
0.03 Giga cells/Liter
Standard Deviation 0.048
|
0.02 Giga cells/Liter
Standard Deviation 0.040
|
|
Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Basophils: Day 11 (Discharge)
|
0.00 Giga cells/Liter
Standard Deviation 0.000
|
0.01 Giga cells/Liter
Standard Deviation 0.025
|
|
Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Platelet count: Baseline (Day -1)
|
276.1 Giga cells/Liter
Standard Deviation 49.55
|
219.3 Giga cells/Liter
Standard Deviation 46.78
|
|
Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Platelet count: Day 11 (Discharge)
|
280.5 Giga cells/Liter
Standard Deviation 67.17
|
221.3 Giga cells/Liter
Standard Deviation 53.04
|
|
Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Neutrophils: Baseline (Day -1)
|
4.56 Giga cells/Liter
Standard Deviation 1.563
|
3.11 Giga cells/Liter
Standard Deviation 0.559
|
|
Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Neutrophils: Day 11 (Discharge)
|
4.20 Giga cells/Liter
Standard Deviation 1.344
|
2.81 Giga cells/Liter
Standard Deviation 0.521
|
|
Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Lymphocytes: Baseline (Day -1)
|
2.17 Giga cells/Liter
Standard Deviation 0.397
|
2.01 Giga cells/Liter
Standard Deviation 0.359
|
|
Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Lymphocytes: Day 11 (Discharge)
|
2.05 Giga cells/Liter
Standard Deviation 0.431
|
1.98 Giga cells/Liter
Standard Deviation 0.340
|
|
Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Monocytes: Baseline (Day -1)
|
0.35 Giga cells/Liter
Standard Deviation 0.113
|
0.34 Giga cells/Liter
Standard Deviation 0.089
|
|
Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Eosinophils: Baseline (Day -1)
|
0.12 Giga cells/Liter
Standard Deviation 0.044
|
0.13 Giga cells/Liter
Standard Deviation 0.060
|
|
Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Eosinophils: Day 11 (Discharge)
|
0.15 Giga cells/Liter
Standard Deviation 0.052
|
0.16 Giga cells/Liter
Standard Deviation 0.150
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 11 (Discharge)Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
Blood samples were collected for analyzing absolute values of Erythrocytes. Baseline is defined as the latest non-missing pre-dose value
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=13 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=16 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Absolute Values of Hematology Parameter: Erythrocytes
Baseline (Day -1)
|
5.028 Trillion cells/Liter
Standard Deviation 0.6223
|
5.038 Trillion cells/Liter
Standard Deviation 0.4072
|
|
Cohort 2: Absolute Values of Hematology Parameter: Erythrocytes
Day 11 (Discharge)
|
4.575 Trillion cells/Liter
Standard Deviation 0.5669
|
4.826 Trillion cells/Liter
Standard Deviation 0.4039
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 11 (Discharge)Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
Blood samples were collected for analyzing absolute values of Mean Corpuscular Volume (MCV). Baseline is defined as the latest non-missing pre-dose value
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=13 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=16 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)
Baseline (Day -1)
|
89.8 femtoliter (fL)
Standard Deviation 4.10
|
91.3 femtoliter (fL)
Standard Deviation 4.51
|
|
Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)
Day 11 (Discharge)
|
90.3 femtoliter (fL)
Standard Deviation 3.99
|
91.4 femtoliter (fL)
Standard Deviation 4.21
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 11 (Discharge)Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
Blood samples were collected for analyzing absolute values of Mean corpuscular hemoglobin (MCH). Baseline is defined as the latest non-missing pre-dose value
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=13 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=16 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Baseline (Day -1)
|
1.834 femtomole (fmol)
Standard Deviation 0.0868
|
1.851 femtomole (fmol)
Standard Deviation 0.0808
|
|
Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Day 11 (Discharge)
|
1.837 femtomole (fmol)
Standard Deviation 0.0980
|
1.853 femtomole (fmol)
Standard Deviation 0.0919
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 11 (Discharge)Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
Blood samples were collected for analyzing absolute values of Hemoglobin. Baseline is defined as the latest non-missing pre-dose value
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=13 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=16 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Absolute Values of Hematology Parameter: Hemoglobin
Baseline (Day -1)
|
148.25 gram per liter (g/L)
Standard Deviation 18.566
|
149.95 gram per liter (g/L)
Standard Deviation 11.278
|
|
Cohort 2: Absolute Values of Hematology Parameter: Hemoglobin
Day 11 (Discharge)
|
134.99 gram per liter (g/L)
Standard Deviation 16.590
|
143.73 gram per liter (g/L)
Standard Deviation 12.170
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 11 (Discharge)Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
Blood samples were collected for analyzing absolute values of Hematocrit. Baseline is defined as the latest non-missing pre-dose value
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=13 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=16 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Absolute Values of Hematology Parameter: Hematocrit
Baseline (Day -1)
|
0.450 Percentage of red blood cells in blood
Standard Deviation 0.0537
|
0.458 Percentage of red blood cells in blood
Standard Deviation 0.0338
|
|
Cohort 2: Absolute Values of Hematology Parameter: Hematocrit
Day 11 (Discharge)
|
0.412 Percentage of red blood cells in blood
Standard Deviation 0.0487
|
0.440 Percentage of red blood cells in blood
Standard Deviation 0.0344
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 11 (Discharge)Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
Blood samples were collected for analyzing absolute values of Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate aminotransferase (AST) and Creatine Phosphokinase (CPK). Baseline is defined as the latest non-missing pre-dose value
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=13 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=16 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
Day 11 (Discharge), ALP
|
59.8 International Units per Liter (IU/L)
Standard Deviation 12.94
|
60.1 International Units per Liter (IU/L)
Standard Deviation 20.92
|
|
Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
Baseline (Day -1), AST
|
11.13 International Units per Liter (IU/L)
Standard Deviation 3.261
|
14.62 International Units per Liter (IU/L)
Standard Deviation 7.533
|
|
Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
Day 11 (Discharge), AST
|
10.12 International Units per Liter (IU/L)
Standard Deviation 2.481
|
13.72 International Units per Liter (IU/L)
Standard Deviation 13.046
|
|
Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
Baseline (Day -1), CPK
|
87.8 International Units per Liter (IU/L)
Standard Deviation 47.25
|
152.8 International Units per Liter (IU/L)
Standard Deviation 72.50
|
|
Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
Day 11 (Discharge), CPK
|
60.9 International Units per Liter (IU/L)
Standard Deviation 22.91
|
90.0 International Units per Liter (IU/L)
Standard Deviation 34.09
|
|
Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
Baseline (Day -1), ALT
|
19.15 International Units per Liter (IU/L)
Standard Deviation 10.383
|
23.88 International Units per Liter (IU/L)
Standard Deviation 11.661
|
|
Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
Day 11 (Discharge), ALT
|
21.22 International Units per Liter (IU/L)
Standard Deviation 9.945
|
25.63 International Units per Liter (IU/L)
Standard Deviation 18.822
|
|
Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
Baseline (Day -1), ALP
|
64.1 International Units per Liter (IU/L)
Standard Deviation 14.94
|
62.6 International Units per Liter (IU/L)
Standard Deviation 22.40
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 11 (Discharge)Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
Blood samples were collected for analyzing absolute values of direct bilirubin, total bilirubin, total protein and Creatinine. Baseline is defined as the latest non-missing pre-dose value
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=13 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=16 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine
Baseline (Day -1), Direct Bilirubin
|
3.75 micromoles per liter (umol/L)
Standard Deviation 2.021
|
4.68 micromoles per liter (umol/L)
Standard Deviation 2.537
|
|
Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine
Day 11 (Discharge), Direct Bilirubin
|
3.58 micromoles per liter (umol/L)
Standard Deviation 2.523
|
4.18 micromoles per liter (umol/L)
Standard Deviation 2.461
|
|
Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine
Baseline (Day -1), Total Bilirubin
|
16.7 micromoles per liter (umol/L)
Standard Deviation 16.45
|
16.1 micromoles per liter (umol/L)
Standard Deviation 9.16
|
|
Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine
Day 11 (Discharge), Total Bilirubin
|
11.8 micromoles per liter (umol/L)
Standard Deviation 8.65
|
13.9 micromoles per liter (umol/L)
Standard Deviation 8.43
|
|
Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine
Baseline (Day -1), Total Protein
|
74.8 micromoles per liter (umol/L)
Standard Deviation 2.41
|
71.8 micromoles per liter (umol/L)
Standard Deviation 3.69
|
|
Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine
Day 11 (Discharge), Total Protein
|
68.0 micromoles per liter (umol/L)
Standard Deviation 3.14
|
68.6 micromoles per liter (umol/L)
Standard Deviation 4.38
|
|
Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine
Baseline (Day -1), Creatinine
|
64.8 micromoles per liter (umol/L)
Standard Deviation 12.69
|
71.9 micromoles per liter (umol/L)
Standard Deviation 12.30
|
|
Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine
Day 11 (Discharge), Creatinine
|
61.6 micromoles per liter (umol/L)
Standard Deviation 12.91
|
71.4 micromoles per liter (umol/L)
Standard Deviation 12.77
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 11 (Discharge)Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
Blood samples were collected for analyzing absolute values of Calcium, Sodium and Urea Nitrogen. Baseline is defined as the latest non-missing pre-dose value
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=13 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=16 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen
Day 11 (Discharge), Urea Nitrogen
|
4.18 millimoles per liter (mmol/L)
Standard Deviation 0.877
|
4.38 millimoles per liter (mmol/L)
Standard Deviation 0.913
|
|
Cohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen
Baseline (Day -1), Calcium
|
2.422 millimoles per liter (mmol/L)
Standard Deviation 0.1248
|
2.388 millimoles per liter (mmol/L)
Standard Deviation 0.0683
|
|
Cohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen
Day 11 (Discharge), Calcium
|
2.313 millimoles per liter (mmol/L)
Standard Deviation 0.0598
|
2.341 millimoles per liter (mmol/L)
Standard Deviation 0.1008
|
|
Cohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen
Baseline (Day -1), Sodium
|
138.8 millimoles per liter (mmol/L)
Standard Deviation 1.69
|
139.1 millimoles per liter (mmol/L)
Standard Deviation 2.35
|
|
Cohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen
Day 11 (Discharge), Sodium
|
139.8 millimoles per liter (mmol/L)
Standard Deviation 1.77
|
140.4 millimoles per liter (mmol/L)
Standard Deviation 1.55
|
|
Cohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen
Baseline (Day -1), Urea Nitrogen
|
4.33 millimoles per liter (mmol/L)
Standard Deviation 1.637
|
5.39 millimoles per liter (mmol/L)
Standard Deviation 0.998
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 1.5, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]Population: Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected for analyzing absolute values of glucose and potassium
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Baseline (Pre-dose at Day 1 [Period 1]), Glucose
|
4.84 millimoles per liter (mmol/L)
Standard Deviation 0.303
|
4.99 millimoles per liter (mmol/L)
Standard Deviation 0.336
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 1: Post-dose at 15 minutes (Period 1), Glucose
|
5.04 millimoles per liter (mmol/L)
Standard Deviation 0.804
|
4.96 millimoles per liter (mmol/L)
Standard Deviation 1.030
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 1: Post-dose at 30 minutes (Period 1), Glucose
|
5.08 millimoles per liter (mmol/L)
Standard Deviation 0.558
|
4.96 millimoles per liter (mmol/L)
Standard Deviation 0.623
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 1: Post-dose at 1 hour (Period 1), Glucose
|
5.26 millimoles per liter (mmol/L)
Standard Deviation 0.403
|
4.96 millimoles per liter (mmol/L)
Standard Deviation 0.320
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 1: Post-dose at 1.5 hours (Period 1), Glucose
|
5.09 millimoles per liter (mmol/L)
Standard Deviation 0.474
|
4.98 millimoles per liter (mmol/L)
Standard Deviation 0.277
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 1: Post-dose at 2 hours (Period 1), Glucose
|
4.94 millimoles per liter (mmol/L)
Standard Deviation 0.422
|
4.88 millimoles per liter (mmol/L)
Standard Deviation 0.349
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 1: Post-dose at 4 hours (Period 1), Glucose
|
4.59 millimoles per liter (mmol/L)
Standard Deviation 0.297
|
4.74 millimoles per liter (mmol/L)
Standard Deviation 0.239
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Baseline (Pre-dose at Day 4 [Period 2]), Glucose
|
4.81 millimoles per liter (mmol/L)
Standard Deviation 0.253
|
4.74 millimoles per liter (mmol/L)
Standard Deviation 0.334
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 4: Post-dose at 15 minutes (Period 2), Glucose
|
4.97 millimoles per liter (mmol/L)
Standard Deviation 1.605
|
4.72 millimoles per liter (mmol/L)
Standard Deviation 0.998
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 4: Post-dose at 30 minutes (Period 2), Glucose
|
4.89 millimoles per liter (mmol/L)
Standard Deviation 1.056
|
4.96 millimoles per liter (mmol/L)
Standard Deviation 0.658
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 4: Post-dose at 1 hour (Period 2), Glucose
|
4.88 millimoles per liter (mmol/L)
Standard Deviation 0.473
|
4.97 millimoles per liter (mmol/L)
Standard Deviation 0.397
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 4: Post-dose at 1.5 hours (Period 2), Glucose
|
4.92 millimoles per liter (mmol/L)
Standard Deviation 0.550
|
4.78 millimoles per liter (mmol/L)
Standard Deviation 0.444
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 4: Post-dose at 2 hours (Period 2), Glucose
|
4.74 millimoles per liter (mmol/L)
Standard Deviation 0.334
|
4.54 millimoles per liter (mmol/L)
Standard Deviation 0.371
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 4: Post-dose at 4 hours (Period 2), Glucose
|
4.66 millimoles per liter (mmol/L)
Standard Deviation 0.225
|
4.52 millimoles per liter (mmol/L)
Standard Deviation 0.308
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Baseline (Pre-dose at Day 7 [Period 3]), Glucose
|
4.84 millimoles per liter (mmol/L)
Standard Deviation 0.242
|
4.72 millimoles per liter (mmol/L)
Standard Deviation 0.368
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 7: Post-dose at 15 minutes (Period 3), Glucose
|
5.01 millimoles per liter (mmol/L)
Standard Deviation 0.936
|
5.07 millimoles per liter (mmol/L)
Standard Deviation 0.948
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 7: Post-dose at 30 minutes (Period 3), Glucose
|
4.75 millimoles per liter (mmol/L)
Standard Deviation 0.516
|
5.05 millimoles per liter (mmol/L)
Standard Deviation 0.715
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 7: Post-dose at 1 hour (Period 3), Glucose
|
4.84 millimoles per liter (mmol/L)
Standard Deviation 0.426
|
5.05 millimoles per liter (mmol/L)
Standard Deviation 0.425
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 7: Post-dose at 1.5 hours (Period 3), Glucose
|
4.73 millimoles per liter (mmol/L)
Standard Deviation 0.382
|
5.02 millimoles per liter (mmol/L)
Standard Deviation 0.400
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 7: Post-dose at 2 hours (Period 3), Glucose
|
4.66 millimoles per liter (mmol/L)
Standard Deviation 0.359
|
4.68 millimoles per liter (mmol/L)
Standard Deviation 0.383
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 7: Post-dose at 4 hours (Period 3), Glucose
|
4.71 millimoles per liter (mmol/L)
Standard Deviation 0.154
|
4.57 millimoles per liter (mmol/L)
Standard Deviation 0.315
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Baseline (Pre-dose at Day 10 (Period 4), Glucose
|
4.67 millimoles per liter (mmol/L)
Standard Deviation 0.293
|
4.83 millimoles per liter (mmol/L)
Standard Deviation 0.286
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 10: Post-dose at 15 minutes (Period 4), Glucose
|
4.62 millimoles per liter (mmol/L)
Standard Deviation 0.887
|
5.23 millimoles per liter (mmol/L)
Standard Deviation 1.006
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 10: Post-dose at 30 minutes (Period 4), Glucose
|
4.77 millimoles per liter (mmol/L)
Standard Deviation 0.786
|
4.91 millimoles per liter (mmol/L)
Standard Deviation 0.692
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 10: Post-dose at 1 hour (Period 4), Glucose
|
4.88 millimoles per liter (mmol/L)
Standard Deviation 0.285
|
4.79 millimoles per liter (mmol/L)
Standard Deviation 0.512
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 10: Post-dose at 1.5 hours (Period 4), Glucose
|
4.81 millimoles per liter (mmol/L)
Standard Deviation 0.411
|
4.73 millimoles per liter (mmol/L)
Standard Deviation 0.368
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 10: Post-dose at 2 hours (Period 4), Glucose
|
4.62 millimoles per liter (mmol/L)
Standard Deviation 0.349
|
4.66 millimoles per liter (mmol/L)
Standard Deviation 0.316
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 10: Post-dose at 4 hours (Period 4), Glucose
|
4.59 millimoles per liter (mmol/L)
Standard Deviation 0.355
|
4.68 millimoles per liter (mmol/L)
Standard Deviation 0.235
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Baseline (Pre-dose at Day 1 [Period 1]), Potassium
|
4.28 millimoles per liter (mmol/L)
Standard Deviation 0.212
|
4.39 millimoles per liter (mmol/L)
Standard Deviation 0.295
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 1: Post-dose at 15 minutes (Period 1), Potassium
|
4.36 millimoles per liter (mmol/L)
Standard Deviation 0.365
|
4.32 millimoles per liter (mmol/L)
Standard Deviation 0.128
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 1: Post-dose at 30 minutes (Period 1), Potassium
|
4.25 millimoles per liter (mmol/L)
Standard Deviation 0.301
|
4.37 millimoles per liter (mmol/L)
Standard Deviation 0.296
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 1: Post-dose at 1 hour (Period 1), Potassium
|
4.22 millimoles per liter (mmol/L)
Standard Deviation 0.345
|
4.23 millimoles per liter (mmol/L)
Standard Deviation 0.140
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 1: Post-dose at 1.5 hours (Period 1), Potassium
|
4.20 millimoles per liter (mmol/L)
Standard Deviation 0.277
|
4.28 millimoles per liter (mmol/L)
Standard Deviation 0.402
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 1: Post-dose at 2 hours (Period 1), Potassium
|
4.30 millimoles per liter (mmol/L)
Standard Deviation 0.499
|
4.16 millimoles per liter (mmol/L)
Standard Deviation 0.131
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 1: Post-dose at 4 hours (Period 1), Potassium
|
4.12 millimoles per liter (mmol/L)
Standard Deviation 0.142
|
4.06 millimoles per liter (mmol/L)
Standard Deviation 0.163
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Baseline (Pre-dose at Day 4 [Period 2]), Potassium
|
4.28 millimoles per liter (mmol/L)
Standard Deviation 0.191
|
4.29 millimoles per liter (mmol/L)
Standard Deviation 0.209
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 4: Post-dose at 15 minutes (Period 2), Potassium
|
4.37 millimoles per liter (mmol/L)
Standard Deviation 0.235
|
4.10 millimoles per liter (mmol/L)
Standard Deviation 0.321
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 4: Post-dose at 30 minutes (Period 2), Potassium
|
4.31 millimoles per liter (mmol/L)
Standard Deviation 0.241
|
4.38 millimoles per liter (mmol/L)
Standard Deviation 0.561
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 4: Post-dose at 1 hour (Period 2), Potassium
|
4.19 millimoles per liter (mmol/L)
Standard Deviation 0.161
|
4.20 millimoles per liter (mmol/L)
Standard Deviation 0.238
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 4: Post-dose at 1.5 hours (Period 2), Potassium
|
4.11 millimoles per liter (mmol/L)
Standard Deviation 0.139
|
4.27 millimoles per liter (mmol/L)
Standard Deviation 0.371
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 4: Post-dose at 2 hours (Period 2), Potassium
|
4.25 millimoles per liter (mmol/L)
Standard Deviation 0.515
|
4.13 millimoles per liter (mmol/L)
Standard Deviation 0.206
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 4: Post-dose at 4 hours (Period 2), Potassium
|
4.14 millimoles per liter (mmol/L)
Standard Deviation 0.271
|
4.18 millimoles per liter (mmol/L)
Standard Deviation 0.241
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Baseline (Pre-dose at Day 7 [Period 3]), Potassium
|
4.28 millimoles per liter (mmol/L)
Standard Deviation 0.142
|
4.30 millimoles per liter (mmol/L)
Standard Deviation 0.153
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 7: Post-dose at 15 minutes (Period 3), Potassium
|
4.13 millimoles per liter (mmol/L)
Standard Deviation 0.153
|
4.25 millimoles per liter (mmol/L)
Standard Deviation 0.185
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 7: Post-dose at 30 minutes (Period 3), Potassium
|
4.21 millimoles per liter (mmol/L)
Standard Deviation 0.216
|
4.31 millimoles per liter (mmol/L)
Standard Deviation 0.218
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 7: Post-dose at 1 hour (Period 3), Potassium
|
4.14 millimoles per liter (mmol/L)
Standard Deviation 0.178
|
4.19 millimoles per liter (mmol/L)
Standard Deviation 0.278
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 7: Post-dose at 1.5 hours (Period 3), Potassium
|
4.27 millimoles per liter (mmol/L)
Standard Deviation 0.613
|
4.18 millimoles per liter (mmol/L)
Standard Deviation 0.244
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 7: Post-dose at 2 hours (Period 3), Potassium
|
4.12 millimoles per liter (mmol/L)
Standard Deviation 0.180
|
4.28 millimoles per liter (mmol/L)
Standard Deviation 0.339
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 7: Post-dose at 4 hours (Period 3), Potassium
|
4.12 millimoles per liter (mmol/L)
Standard Deviation 0.279
|
4.20 millimoles per liter (mmol/L)
Standard Deviation 0.183
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Baseline (Pre-dose at Day 10 (Period 4), Potassium
|
4.52 millimoles per liter (mmol/L)
Standard Deviation 0.440
|
4.35 millimoles per liter (mmol/L)
Standard Deviation 0.234
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 10: Post-dose at 15 minutes (Period 4), Potassium
|
4.22 millimoles per liter (mmol/L)
Standard Deviation 0.249
|
4.29 millimoles per liter (mmol/L)
Standard Deviation 0.294
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 10: Post-dose at 30 minutes (Period 4), Potassium
|
4.40 millimoles per liter (mmol/L)
Standard Deviation 0.422
|
4.26 millimoles per liter (mmol/L)
Standard Deviation 0.193
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 10: Post-dose at 1 hour (Period 4), Potassium
|
4.22 millimoles per liter (mmol/L)
Standard Deviation 0.231
|
4.20 millimoles per liter (mmol/L)
Standard Deviation 0.171
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 10: Post-dose at 1.5 hours (Period 4), Potassium
|
4.17 millimoles per liter (mmol/L)
Standard Deviation 0.180
|
4.13 millimoles per liter (mmol/L)
Standard Deviation 0.134
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 10: Post-dose at 4 hours (Period 4), Potassium
|
4.15 millimoles per liter (mmol/L)
Standard Deviation 0.194
|
4.12 millimoles per liter (mmol/L)
Standard Deviation 0.256
|
|
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Day 10: Post-dose at 2 hours (Period 4), Potassium
|
4.22 millimoles per liter (mmol/L)
Standard Deviation 0.228
|
4.07 millimoles per liter (mmol/L)
Standard Deviation 0.162
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]Population: Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.
SBP and DBP measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Manual techniques were used only if an automated device was not available.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 4: Post-dose at 15 minutes (Period 2), DBP
|
61.4 millimeters of mercury(mmHg)
Standard Deviation 5.33
|
66.5 millimeters of mercury(mmHg)
Standard Deviation 7.91
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 4: Post-dose at 30 minutes (Period 2), DBP
|
61.8 millimeters of mercury(mmHg)
Standard Deviation 7.11
|
68.9 millimeters of mercury(mmHg)
Standard Deviation 8.53
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 4: Post-dose at 1 hour (Period 2), DBP
|
61.4 millimeters of mercury(mmHg)
Standard Deviation 4.30
|
67.9 millimeters of mercury(mmHg)
Standard Deviation 8.11
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 4: Post-dose at 4 hours (Period 2), DBP
|
63.1 millimeters of mercury(mmHg)
Standard Deviation 5.44
|
68.5 millimeters of mercury(mmHg)
Standard Deviation 7.45
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Baseline (Pre-dose at Day 7 [Period 3]), DBP
|
65.8 millimeters of mercury(mmHg)
Standard Deviation 5.30
|
70.6 millimeters of mercury(mmHg)
Standard Deviation 7.83
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 7: Post-dose at 15 minutes (Period 3), DBP
|
63.0 millimeters of mercury(mmHg)
Standard Deviation 4.26
|
67.5 millimeters of mercury(mmHg)
Standard Deviation 7.01
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 7: Post-dose at 30 minutes (Period 3), DBP
|
63.0 millimeters of mercury(mmHg)
Standard Deviation 4.58
|
66.6 millimeters of mercury(mmHg)
Standard Deviation 6.50
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 7: Post-dose at 1 hour (Period 3), DBP
|
62.7 millimeters of mercury(mmHg)
Standard Deviation 3.48
|
65.8 millimeters of mercury(mmHg)
Standard Deviation 7.96
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 7: Post-dose at 2 hours (Period 3), DBP
|
62.9 millimeters of mercury(mmHg)
Standard Deviation 3.92
|
67.0 millimeters of mercury(mmHg)
Standard Deviation 5.12
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 7: Post-dose at 4 hours (Period 3), DBP
|
64.4 millimeters of mercury(mmHg)
Standard Deviation 4.73
|
68.5 millimeters of mercury(mmHg)
Standard Deviation 7.48
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 10: Post-dose at 15 minutes (Period 4), DBP
|
67.8 millimeters of mercury(mmHg)
Standard Deviation 7.78
|
62.2 millimeters of mercury(mmHg)
Standard Deviation 6.75
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Baseline (Pre-dose at Day 1 [Period 1]), SBP
|
109.9 millimeters of mercury(mmHg)
Standard Deviation 8.61
|
108.3 millimeters of mercury(mmHg)
Standard Deviation 6.78
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 1: Post-dose at 15 minutes (Period 1), SBP
|
114.9 millimeters of mercury(mmHg)
Standard Deviation 12.04
|
113.8 millimeters of mercury(mmHg)
Standard Deviation 9.52
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 1: Post-dose at 30 minutes (Period 1), SBP
|
114.6 millimeters of mercury(mmHg)
Standard Deviation 9.50
|
113.8 millimeters of mercury(mmHg)
Standard Deviation 8.71
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 1: Post-dose at 1 hour (Period 1), SBP
|
110.4 millimeters of mercury(mmHg)
Standard Deviation 8.25
|
110.8 millimeters of mercury(mmHg)
Standard Deviation 9.66
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 1: Post-dose at 2 hours (Period 1), SBP
|
106.9 millimeters of mercury(mmHg)
Standard Deviation 8.09
|
110.4 millimeters of mercury(mmHg)
Standard Deviation 11.43
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 1: Post-dose at 4 hours (Period 1), SBP
|
109.4 millimeters of mercury(mmHg)
Standard Deviation 7.37
|
109.1 millimeters of mercury(mmHg)
Standard Deviation 7.05
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 4: Post-dose at 15 minutes (Period 2), SBP
|
111.7 millimeters of mercury(mmHg)
Standard Deviation 10.44
|
115.2 millimeters of mercury(mmHg)
Standard Deviation 11.87
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 4: Post-dose at 30 minutes (Period 2), SBP
|
111.3 millimeters of mercury(mmHg)
Standard Deviation 11.47
|
116.4 millimeters of mercury(mmHg)
Standard Deviation 11.17
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 4: Post-dose at 1 hour (Period 2), SBP
|
110.9 millimeters of mercury(mmHg)
Standard Deviation 9.21
|
110.6 millimeters of mercury(mmHg)
Standard Deviation 9.87
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 4: Post-dose at 2 hours (Period 2), SBP
|
105.8 millimeters of mercury(mmHg)
Standard Deviation 7.30
|
105.4 millimeters of mercury(mmHg)
Standard Deviation 7.95
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 4: Post-dose at 4 hours (Period 2), SBP
|
108.8 millimeters of mercury(mmHg)
Standard Deviation 9.64
|
109.2 millimeters of mercury(mmHg)
Standard Deviation 10.94
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Baseline (Pre-dose at Day 7 [Period 3]), SBP
|
109.9 millimeters of mercury(mmHg)
Standard Deviation 8.04
|
107.5 millimeters of mercury(mmHg)
Standard Deviation 8.03
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 7: Post-dose at 15 minutes (Period 3), SBP
|
112.9 millimeters of mercury(mmHg)
Standard Deviation 12.96
|
112.8 millimeters of mercury(mmHg)
Standard Deviation 9.89
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 7: Post-dose at 1 hour (Period 3), SBP
|
110.4 millimeters of mercury(mmHg)
Standard Deviation 9.05
|
108.4 millimeters of mercury(mmHg)
Standard Deviation 9.77
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 7: Post-dose at 2 hours (Period 3), SBP
|
107.8 millimeters of mercury(mmHg)
Standard Deviation 8.63
|
105.7 millimeters of mercury(mmHg)
Standard Deviation 7.90
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 7: Post-dose at 4 hours (Period 3), SBP
|
109.4 millimeters of mercury(mmHg)
Standard Deviation 7.44
|
108.8 millimeters of mercury(mmHg)
Standard Deviation 8.04
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Baseline (Pre-dose at Day 10 (Period 4), SBP
|
108.8 millimeters of mercury(mmHg)
Standard Deviation 7.06
|
108.4 millimeters of mercury(mmHg)
Standard Deviation 10.20
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 10: Post-dose at 15 minutes (Period 4), SBP
|
113.5 millimeters of mercury(mmHg)
Standard Deviation 12.44
|
113.9 millimeters of mercury(mmHg)
Standard Deviation 12.37
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 10: Post-dose at 30 minutes (Period 4), SBP
|
110.8 millimeters of mercury(mmHg)
Standard Deviation 8.47
|
112.9 millimeters of mercury(mmHg)
Standard Deviation 11.75
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 10: Post-dose at 1 hour (Period 4), SBP
|
110.1 millimeters of mercury(mmHg)
Standard Deviation 11.02
|
111.6 millimeters of mercury(mmHg)
Standard Deviation 10.18
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Baseline (Pre-dose at Day 1 [Period 1]), DBP
|
68.9 millimeters of mercury(mmHg)
Standard Deviation 7.00
|
64.9 millimeters of mercury(mmHg)
Standard Deviation 3.59
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 1: Post-dose at 15 minutes (Period 1), DBP
|
66.2 millimeters of mercury(mmHg)
Standard Deviation 7.29
|
62.6 millimeters of mercury(mmHg)
Standard Deviation 5.24
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 1: Post-dose at 30 minutes (Period 1), DBP
|
69.1 millimeters of mercury(mmHg)
Standard Deviation 6.74
|
63.2 millimeters of mercury(mmHg)
Standard Deviation 3.82
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 1: Post-dose at 1 hour (Period 1), DBP
|
69.4 millimeters of mercury(mmHg)
Standard Deviation 7.27
|
61.5 millimeters of mercury(mmHg)
Standard Deviation 5.18
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 1: Post-dose at 2 hours (Period 1), DBP
|
67.4 millimeters of mercury(mmHg)
Standard Deviation 6.58
|
62.5 millimeters of mercury(mmHg)
Standard Deviation 5.25
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 1: Post-dose at 4 hours (Period 1), DBP
|
67.3 millimeters of mercury(mmHg)
Standard Deviation 6.26
|
64.6 millimeters of mercury(mmHg)
Standard Deviation 5.78
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 10: Post-dose at 30 minutes (Period 4), DBP
|
67.0 millimeters of mercury(mmHg)
Standard Deviation 6.92
|
61.1 millimeters of mercury(mmHg)
Standard Deviation 6.77
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Baseline (Pre-dose at Day 4 [Period 2]), SBP
|
106.9 millimeters of mercury(mmHg)
Standard Deviation 10.16
|
106.6 millimeters of mercury(mmHg)
Standard Deviation 8.20
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 7: Post-dose at 30 minutes (Period 3), SBP
|
112.8 millimeters of mercury(mmHg)
Standard Deviation 10.05
|
114.1 millimeters of mercury(mmHg)
Standard Deviation 8.71
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 10: Post-dose at 2 hours (Period 4), SBP
|
105.3 millimeters of mercury(mmHg)
Standard Deviation 9.70
|
108.4 millimeters of mercury(mmHg)
Standard Deviation 8.34
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 10: Post-dose at 4 hours (Period 4), SBP
|
106.5 millimeters of mercury(mmHg)
Standard Deviation 9.90
|
108.6 millimeters of mercury(mmHg)
Standard Deviation 8.02
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Baseline (Pre-dose at Day 4 [Period 2]), DBP
|
64.1 millimeters of mercury(mmHg)
Standard Deviation 6.56
|
70.1 millimeters of mercury(mmHg)
Standard Deviation 7.09
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 4: Post-dose at 2 hours (Period 2), DBP
|
60.9 millimeters of mercury(mmHg)
Standard Deviation 4.53
|
66.9 millimeters of mercury(mmHg)
Standard Deviation 5.88
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Baseline (Pre-dose at Day 10 (Period 4), DBP
|
67.6 millimeters of mercury(mmHg)
Standard Deviation 6.76
|
64.9 millimeters of mercury(mmHg)
Standard Deviation 4.94
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 10: Post-dose at 1 hour (Period 4), DBP
|
66.8 millimeters of mercury(mmHg)
Standard Deviation 7.83
|
62.8 millimeters of mercury(mmHg)
Standard Deviation 5.21
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 10: Post-dose at 2 hours (Period 4), DBP
|
66.2 millimeters of mercury(mmHg)
Standard Deviation 6.62
|
62.5 millimeters of mercury(mmHg)
Standard Deviation 5.30
|
|
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Day 10: Post-dose at 4 hours (Period 4), DBP
|
66.0 millimeters of mercury(mmHg)
Standard Deviation 7.97
|
61.1 millimeters of mercury(mmHg)
Standard Deviation 4.40
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]Population: Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.
Pulse rate measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Manual techniques were used only if an automated device was not available.
Outcome measures
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 Participants
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|
|
Cohort 2: Absolute Values of Pulse Rate (PR)
Day 4: Post-dose at 1 hour (Period 2)
|
64.3 Beats per minute
Standard Deviation 8.27
|
72.9 Beats per minute
Standard Deviation 11.04
|
|
Cohort 2: Absolute Values of Pulse Rate (PR)
Day 4: Post-dose at 2 hours (Period 2)
|
60.0 Beats per minute
Standard Deviation 6.29
|
67.1 Beats per minute
Standard Deviation 11.27
|
|
Cohort 2: Absolute Values of Pulse Rate (PR)
Day 4: Post-dose at 4 hours (Period 2)
|
57.3 Beats per minute
Standard Deviation 7.50
|
63.9 Beats per minute
Standard Deviation 9.84
|
|
Cohort 2: Absolute Values of Pulse Rate (PR)
Baseline (Pre-dose at Day 7 [Period 3])
|
54.9 Beats per minute
Standard Deviation 8.29
|
64.3 Beats per minute
Standard Deviation 11.12
|
|
Cohort 2: Absolute Values of Pulse Rate (PR)
Day 7: Post-dose at 15 minutes (Period 3)
|
68.8 Beats per minute
Standard Deviation 7.93
|
74.2 Beats per minute
Standard Deviation 11.67
|
|
Cohort 2: Absolute Values of Pulse Rate (PR)
Day 7: Post-dose at 30 minutes (Period 3)
|
67.4 Beats per minute
Standard Deviation 8.37
|
73.8 Beats per minute
Standard Deviation 11.78
|
|
Cohort 2: Absolute Values of Pulse Rate (PR)
Day 7: Post-dose at 1 hour (Period 3)
|
65.7 Beats per minute
Standard Deviation 7.29
|
72.9 Beats per minute
Standard Deviation 11.34
|
|
Cohort 2: Absolute Values of Pulse Rate (PR)
Day 7: Post-dose at 2 hours (Period 3)
|
60.9 Beats per minute
Standard Deviation 6.53
|
67.6 Beats per minute
Standard Deviation 10.22
|
|
Cohort 2: Absolute Values of Pulse Rate (PR)
Day 10: Post-dose at 30 minutes (Period 4)
|
77.2 Beats per minute
Standard Deviation 11.18
|
67.9 Beats per minute
Standard Deviation 9.96
|
|
Cohort 2: Absolute Values of Pulse Rate (PR)
Day 10: Post-dose at 1 hour (Period 4)
|
74.4 Beats per minute
Standard Deviation 10.42
|
66.4 Beats per minute
Standard Deviation 8.71
|
|
Cohort 2: Absolute Values of Pulse Rate (PR)
Day 10: Post-dose at 2 hours (Period 4)
|
70.2 Beats per minute
Standard Deviation 10.16
|
61.4 Beats per minute
Standard Deviation 7.71
|
|
Cohort 2: Absolute Values of Pulse Rate (PR)
Day 10: Post-dose at 4 hours (Period 4)
|
67.8 Beats per minute
Standard Deviation 10.21
|
58.3 Beats per minute
Standard Deviation 6.93
|
|
Cohort 2: Absolute Values of Pulse Rate (PR)
Day 7: Post-dose at 4 hours (Period 3)
|
56.9 Beats per minute
Standard Deviation 8.19
|
67.1 Beats per minute
Standard Deviation 11.54
|
|
Cohort 2: Absolute Values of Pulse Rate (PR)
Baseline (Pre-dose at Day 10 (Period 4)
|
65.5 Beats per minute
Standard Deviation 9.36
|
54.0 Beats per minute
Standard Deviation 7.77
|
|
Cohort 2: Absolute Values of Pulse Rate (PR)
Day 10: Post-dose at 15 minutes (Period 4)
|
77.2 Beats per minute
Standard Deviation 11.63
|
69.3 Beats per minute
Standard Deviation 10.00
|
|
Cohort 2: Absolute Values of Pulse Rate (PR)
Day 4: Post-dose at 15 minutes (Period 2)
|
67.1 Beats per minute
Standard Deviation 7.22
|
77.6 Beats per minute
Standard Deviation 14.54
|
|
Cohort 2: Absolute Values of Pulse Rate (PR)
Day 4: Post-dose at 30 minutes (Period 2)
|
64.8 Beats per minute
Standard Deviation 8.12
|
74.8 Beats per minute
Standard Deviation 14.48
|
|
Cohort 2: Absolute Values of Pulse Rate (PR)
Baseline (Pre-dose at Day 1 [Period 1])
|
62.1 Beats per minute
Standard Deviation 11.55
|
51.3 Beats per minute
Standard Deviation 8.75
|
|
Cohort 2: Absolute Values of Pulse Rate (PR)
Day 1: Post-dose at 15 minutes (Period 1)
|
75.8 Beats per minute
Standard Deviation 13.49
|
67.7 Beats per minute
Standard Deviation 8.24
|
|
Cohort 2: Absolute Values of Pulse Rate (PR)
Day 1: Post-dose at 30 minutes (Period 1)
|
75.8 Beats per minute
Standard Deviation 14.89
|
64.0 Beats per minute
Standard Deviation 9.15
|
|
Cohort 2: Absolute Values of Pulse Rate (PR)
Day 1: Post-dose at 1 hour (Period 1)
|
73.0 Beats per minute
Standard Deviation 18.02
|
61.1 Beats per minute
Standard Deviation 8.30
|
|
Cohort 2: Absolute Values of Pulse Rate (PR)
Day 1: Post-dose at 2 hours (Period 1)
|
69.8 Beats per minute
Standard Deviation 13.26
|
57.4 Beats per minute
Standard Deviation 8.33
|
|
Cohort 2: Absolute Values of Pulse Rate (PR)
Day 1: Post-dose at 4 hours (Period 1)
|
66.6 Beats per minute
Standard Deviation 14.31
|
56.4 Beats per minute
Standard Deviation 8.38
|
|
Cohort 2: Absolute Values of Pulse Rate (PR)
Baseline (Pre-dose at Day 4 [Period 2])
|
56.4 Beats per minute
Standard Deviation 5.90
|
62.1 Beats per minute
Standard Deviation 10.92
|
Adverse Events
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 participants at risk
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 participants at risk
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)
n=30 participants at risk
Healthy participants in cohort 2 received Salbutamol HFA-152a via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)
n=30 participants at risk；n=29 participants at risk
Healthy participants in cohort 2 received Salbutamol HFA-134a (Reference) via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|---|---|
|
Psychiatric disorders
Conversion disorder
|
3.3%
1/30 • Number of events 1 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
0.00%
0/29 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
Other adverse events
| Measure |
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)
n=30 participants at risk
Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
n=30 participants at risk
Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)
n=30 participants at risk
Healthy participants in cohort 2 received Salbutamol HFA-152a via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
|
Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)
n=30 participants at risk；n=29 participants at risk
Healthy participants in cohort 2 received Salbutamol HFA-134a (Reference) via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).
|
|---|---|---|---|---|
|
General disorders
Catheter site irritation
|
6.7%
2/30 • Number of events 2 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
6.7%
2/30 • Number of events 2 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
|
General disorders
Catheter site haematoma
|
16.7%
5/30 • Number of events 5 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
|
General disorders
Catheter site related reaction
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
30.0%
9/30 • Number of events 9 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
30.0%
9/30 • Number of events 9 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
|
General disorders
Fatigue
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
10.0%
3/30 • Number of events 3 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
|
Nervous system disorders
Headache
|
10.0%
3/30 • Number of events 3 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
6.7%
2/30 • Number of events 2 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
16.7%
5/30 • Number of events 5 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
33.3%
10/30 • Number of events 10 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
10.0%
3/30 • Number of events 3 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
|
Vascular disorders
Hot flush
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
6.7%
2/30 • Number of events 2 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
10.0%
3/30 • Number of events 4 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
6.7%
2/30 • Number of events 2 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
6.7%
2/30 • Number of events 2 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
6.7%
2/30 • Number of events 3 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
6.7%
2/30 • Number of events 2 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
|
General disorders
Vessel puncture site haematoma
|
6.7%
2/30 • Number of events 2 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
2/30 • Number of events 2 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
0.00%
0/30 • Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Safety Population included all participants who received at least one puff/actuation of study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER