Trial Outcomes & Findings for Pharmacokinetics of Co-administration of Seretide 250 Diskus (HCP0910) and Spiriva Capsule for Inhalation (HGP1011) (NCT NCT02441114)
NCT ID: NCT02441114
Last Updated: 2017-01-11
Results Overview
Area under the concentration of fluticasone versus time curve from the time of dosing to the last measurable concentration
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose
Results posted on
2017-01-11
Participant Flow
Participant milestones
| Measure |
Inhalation of HCP0910 and HGP1011
Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.
The periods were separated with a washout period of 14 days.
|
|---|---|
|
Period1
STARTED
|
10
|
|
Period1
COMPLETED
|
10
|
|
Period1
NOT COMPLETED
|
0
|
|
Washout1
STARTED
|
10
|
|
Washout1
COMPLETED
|
10
|
|
Washout1
NOT COMPLETED
|
0
|
|
Period2
STARTED
|
10
|
|
Period2
COMPLETED
|
10
|
|
Period2
NOT COMPLETED
|
0
|
|
Washout2
STARTED
|
10
|
|
Washout2
COMPLETED
|
6
|
|
Washout2
NOT COMPLETED
|
4
|
|
Period3
STARTED
|
6
|
|
Period3
COMPLETED
|
6
|
|
Period3
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Inhalation of HCP0910 and HGP1011
Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.
The periods were separated with a washout period of 14 days.
|
|---|---|
|
Washout2
Withdrawal by Subject
|
4
|
Baseline Characteristics
Pharmacokinetics of Co-administration of Seretide 250 Diskus (HCP0910) and Spiriva Capsule for Inhalation (HGP1011)
Baseline characteristics by cohort
| Measure |
Inhalation of HCP0910 and HGP1011
n=10 Participants
Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.
The periods were separated with a washout period of 14 days.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
26.8 years
STANDARD_DEVIATION 4.9 • n=99 Participants
|
|
Gender
Female
|
0 Participants
n=99 Participants
|
|
Gender
Male
|
10 Participants
n=99 Participants
|
|
Region of Enrollment
Korea, Republic of
|
10 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dosePopulation: 10 subjects for period 1 and 2; 6 subjects for period 3
Area under the concentration of fluticasone versus time curve from the time of dosing to the last measurable concentration
Outcome measures
| Measure |
Inhalation of HCP0910 and HGP1011
n=10 Participants
Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.
The periods were separated with a washout period of 14 days.
|
|---|---|
|
Area Under the Concentration Versus Time Curve (AUClast)
Period 1
|
686.98 h*pg/mL
Standard Deviation 111.36
|
|
Area Under the Concentration Versus Time Curve (AUClast)
Period 2
|
1247.63 h*pg/mL
Standard Deviation 276.51
|
|
Area Under the Concentration Versus Time Curve (AUClast)
Period 3
|
1769.58 h*pg/mL
Standard Deviation 370.80
|
SECONDARY outcome
Timeframe: Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dosePopulation: 10 subjects for period 1 and 2; 6 subjects for period 3
Time to maximum concentration of fluticasone
Outcome measures
| Measure |
Inhalation of HCP0910 and HGP1011
n=10 Participants
Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.
The periods were separated with a washout period of 14 days.
|
|---|---|
|
Time to Maximum Concentration (Tmax)
Period 1
|
0.76 h
Interval 0.33 to 3.0
|
|
Time to Maximum Concentration (Tmax)
Period 2
|
0.50 h
Interval 0.08 to 1.5
|
|
Time to Maximum Concentration (Tmax)
Period 3
|
0.88 h
Interval 0.33 to 1.5
|
SECONDARY outcome
Timeframe: Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dosePopulation: 10 subjects for period 1 and 2; 6 subjects for period 3
Maximum observed concentration of fluticasone
Outcome measures
| Measure |
Inhalation of HCP0910 and HGP1011
n=10 Participants
Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.
The periods were separated with a washout period of 14 days.
|
|---|---|
|
Maximum Observed Concentration (Cmax)
Period 1
|
95.70 pg/mL
Standard Deviation 20.14
|
|
Maximum Observed Concentration (Cmax)
Period 2
|
173.56 pg/mL
Standard Deviation 44.32
|
|
Maximum Observed Concentration (Cmax)
Period 3
|
246.77 pg/mL
Standard Deviation 57.30
|
Adverse Events
HCP0910 and HGP1011
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HCP0910 and HGP1011
n=10 participants at risk
Single Inhalation of HCP0910 and HGP1011 (Open-label, Single-arm, Single dosing, Dose-escalation)
HCP0910 and HGP1011: Inhalation of HCP0910 (Seretide 250 diskus (Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 72.5 mcg)) and HGP1011 (Spiriva capsule for inhalation (Micronized Tiotropium Bromide Monohydrate 22.5 mcg))
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
10/10 • Number of events 27
|
Additional Information
Clinical Pharmacology and Therapeutics
Seoul National University Hospital
Phone: 82-2-2072-4081
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place