Trial Outcomes & Findings for Sensitivity of Pharmacokinetics to Differences in Aerodynamic Particle Size Distribution (NCT NCT01966692)
NCT ID: NCT01966692
Last Updated: 2024-05-06
Results Overview
Area under the plasma concentration versus time curve from time zero (pre-dose) to the last quantifiable concentration after pulmonary dose (estimated from anatomical throats) normalization; measured as picograms multiplied by hours divided by milliliters (pg\*h/mL).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Day 1 of Periods 1, 2, 3, and 4: pre-dose (15 minutes prior to the dosing), and 5, 10, 15, 20, 30, 45, 60 minutes, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours (+/- 1 hour) post-dose
Results posted on
2024-05-06
Participant Flow
17 participants screen failed. Total number of participants enrolled into the study was 24.
Participant milestones
| Measure |
Fluticasone Propionate Formulation Sequence 1233*
Fluticasone Propionate Drug formulation 1 (500mcg single dose, 1 day), at least 5 days washout, Fluticasone Propionate Drug formulation 2 (500mcg single dose, 1 day), at least 5 days washout, Fluticasone Propionate Drug formulation 3 (500mcg single dose, 1 day), at least 5 days washout, Fluticasone Propionate Drug formulation 3\* (500mcg single dose, 1 day)
See Formulation Development in Detailed Description for details regarding differences in formulations.
\*(The asterisk) A different set of capsules from the same batch of formulation 3 is given to the subject to assess the within-subject variability and to ensure that the study is sufficiently powered to show bioequivalence between two replicates of the same formulation.
|
Fluticasone Propionate Formulation Sequence 23*13
Fluticasone Propionate Formulation Sequence 23\*13
Fluticasone Propionate Drug formulation 2 (500mcg single dose, 1 day), at least 5 days washout, Fluticasone Propionate Drug formulation 3\* (500mcg single dose, 1 day), at least 5 days washout, Fluticasone Propionate Drug formulation 1 (500mcg single dose, 1 day), at least 5 days washout, Fluticasone Propionate Drug formulation 3 (500mcg single dose, 1 day)
See Formulation Development in Detailed Description for details regarding differences in formulations.
\*(The asterisk) A different set of capsules from the same batch of formulation 3 is given to the subject to assess the within-subject variability and to ensure that the study is sufficiently powered to show bioequivalence between two replicates of the same formulation.
|
Fluticasone Propionate Formulation Sequence 313*2
Fluticasone Propionate Drug formulation 3 (500mcg single dose, 1 day), at least 5 days washout, Fluticasone Propionate Drug formulation 1 (500mcg single dose, 1 day), at least 5 days washout, Fluticasone Propionate Drug formulation 3\* (500mcg single dose, 1 day), at least 5 days washout, Fluticasone Propionate Drug formulation 2 (500mcg single dose, 1 day)
See Formulation Development in Detailed Description for details regarding differences in formulations.
\*(The asterisk) A different set of capsules from the same batch of formulation 3 is given to the subject to assess the within-subject variability and to ensure that the study is sufficiently powered to show bioequivalence between two replicates of the same formulation.
|
Fluticasone Propionate Formulation Sequence 3*321
Fluticasone Propionate Formulation Sequence 3\*321
Fluticasone Propionate Drug formulation 3\* (500mcg single dose, 1 day), at least 5 days washout, Fluticasone Propionate Drug formulation 3 (500mcg single dose, 1 day), at least 5 days washout, Fluticasone Propionate Drug formulation 2 (500mcg single dose, 1 day), at least 5 days washout, Fluticasone Propionate Drug formulation 1 (500mcg single dose, 1 day)
See Formulation Development in Detailed Description for details regarding differences in formulations.
\*(The asterisk) A different set of capsules from the same batch of formulation 3 is given to the subject to assess the within-subject variability and to ensure that the study is sufficiently powered to show bioequivalence between two replicates of the same formulation.
|
|---|---|---|---|---|
|
Period 1
STARTED
|
6
|
6
|
6
|
6
|
|
Period 1
COMPLETED
|
6
|
6
|
6
|
6
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
6
|
6
|
6
|
6
|
|
Period 2
COMPLETED
|
6
|
6
|
6
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
6
|
6
|
6
|
6
|
|
Period 3
COMPLETED
|
6
|
6
|
6
|
6
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 4
STARTED
|
6
|
6
|
6
|
6
|
|
Period 4
COMPLETED
|
6
|
6
|
6
|
6
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sensitivity of Pharmacokinetics to Differences in Aerodynamic Particle Size Distribution
Baseline characteristics by cohort
| Measure |
Fluticasone Propionate Formulation Sequence 1233*
n=6 Participants
Fluticasone Propionate Drug formulation 1 (500mcg single dose, 1 day), at least 5 days washout, Fluticasone Propionate Drug formulation 2 (500mcg single dose, 1 day), at least 5 days washout, Fluticasone Propionate Drug formulation 3 (500mcg single dose, 1 day), at least 5 days washout, Fluticasone Propionate Drug formulation 3\* (500mcg single dose, 1 day)
See Formulation Development in Detailed Description for details regarding differences in formulations.
\*(The asterisk) A different set of capsules from the same batch of formulation 3 is given to the subject to assess the within-subject variability and to ensure that the study is sufficiently powered to show bioequivalence between two replicates of the same formulation.
|
Fluticasone Propionate Formulation Dequence 23*13
n=6 Participants
Fluticasone Propionate Drug formulation 2 (500mcg single dose, 1 day), at least 5 days washout, Fluticasone Propionate Drug formulation 3\* (500mcg single dose, 1 day), at least 5 days washout, Fluticasone Propionate Drug formulation 1 (500mcg single dose, 1 day), at least 5 days washout, Fluticasone Propionate Drug formulation 3 (500mcg single dose, 1 day)
See Formulation Development in Detailed Description for details regarding differences in formulations.
\*(The asterisk) A different set of capsules from the same batch of formulation 3 is given to the subject to assess the within-subject variability and to ensure that the study is sufficiently powered to show bioequivalence between two replicates of the same formulation.
|
Fluticasone Propionate Formulation Sequence 313*2
n=6 Participants
Fluticasone Propionate Drug formulation 3 (500mcg single dose, 1 day), at least 5 days washout, Fluticasone Propionate Drug formulation 1 (500mcg single dose, 1 day), at least 5 days washout, Fluticasone Propionate Drug formulation 3\* (500mcg single dose, 1 day), at least 5 days washout, Fluticasone Propionate Drug formulation 2 (500mcg single dose, 1 day)
See Formulation Development in Detailed Description for details regarding differences in formulations.
\*(The asterisk) A different set of capsules from the same batch of formulation 3 is given to the subject to assess the within-subject variability and to ensure that the study is sufficiently powered to show bioequivalence between two replicates of the same formulation.
|
Fluticasone Propionate Formulation Sequence 3*321
n=6 Participants
Fluticasone Propionate Drug formulation 3\* (500mcg single dose, 1 day), at least 5 days washout, Fluticasone Propionate Drug formulation 3 (500mcg single dose, 1 day), at least 5 days washout, Fluticasone Propionate Drug formulation 2 (500mcg single dose, 1 day), at least 5 days washout, Fluticasone Propionate Drug formulation 1 (500mcg single dose, 1 day)
See Formulation Development in Detailed Description for details regarding differences in formulations.
\*(The asterisk) A different set of capsules from the same batch of formulation 3 is given to the subject to assess the within-subject variability and to ensure that the study is sufficiently powered to show bioequivalence between two replicates of the same formulation.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
6 participants
n=206 Participants
|
6 participants
n=7 Participants
|
24 participants
n=31 Participants
|
|
Weight (kg)
|
62.6 kg
n=99 Participants
|
61.6 kg
n=107 Participants
|
64.6 kg
n=206 Participants
|
69.5 kg
n=7 Participants
|
64.7 kg
n=31 Participants
|
|
Age, Continuous
|
22.17 years
n=99 Participants
|
21.67 years
n=107 Participants
|
20.67 years
n=206 Participants
|
26.33 years
n=7 Participants
|
22.71 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Height (cm)
|
169.0 cm
n=99 Participants
|
164.5 cm
n=107 Participants
|
162.7 cm
n=206 Participants
|
172.2 cm
n=7 Participants
|
167.1 cm
n=31 Participants
|
|
BMI
|
22.00 kg/m2
n=99 Participants
|
22.87 kg/m2
n=107 Participants
|
24.4 kg/m2
n=206 Participants
|
23.4 kg/m2
n=7 Participants
|
23.17 kg/m2
n=31 Participants
|
|
FEV1 (L)
|
3.48 L/s
n=99 Participants
|
3.14 L/s
n=107 Participants
|
3.28 L/s
n=206 Participants
|
3.97 L/s
n=7 Participants
|
3.47 L/s
n=31 Participants
|
|
FEV1/FVC
|
0.892 ratio
n=99 Participants
|
0.853 ratio
n=107 Participants
|
0.862 ratio
n=206 Participants
|
0.875 ratio
n=7 Participants
|
0.870 ratio
n=31 Participants
|
PRIMARY outcome
Timeframe: Day 1 of Periods 1, 2, 3, and 4: pre-dose (15 minutes prior to the dosing), and 5, 10, 15, 20, 30, 45, 60 minutes, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours (+/- 1 hour) post-dosePopulation: Pharmacokinetic parameter analysis (PK) population: all participants were randomized and treated and had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=number of participants contributing to the mean.
Area under the plasma concentration versus time curve from time zero (pre-dose) to the last quantifiable concentration after pulmonary dose (estimated from anatomical throats) normalization; measured as picograms multiplied by hours divided by milliliters (pg\*h/mL).
Outcome measures
| Measure |
Fluticasone Propionate Formulation 1 (A-4.5 µm)
n=24 Participants
Fluticasone Propionate dry powder inhaler formulation 1 (A-4.5 µm) administered via Plastiape Monodose Dry powder Inhaler on Day 1 of study period, 500mcg single dose (administered as 5 capsules and each capsule was inhaled at least two times).
|
Fluticasone Propionate Formulation 2 (B-3.8 µm)
n=24 Participants
Fluticasone Propionate dry powder inhaler formulation 2 (B-3.8 µm) administered via Plastiape Monodose Dry powder Inhaler on Day 1 of study period, 500mcg single dose (administered as 5 capsules and each capsule was inhaled at least two times).
|
Fluticasone Propionate Formulation 3 (C-3.7 µm)
n=24 Participants
Fluticasone Propionate dry powder inhaler formulation 3 (C-3.7 µm) administered via Plastiape Monodose Dry powder Inhaler on Day 1 of study period, 500mcg single dose (administered as 5 capsules and each capsule was inhaled at least two times).
|
Fluticasone Propionate Formulation 3 (C-3.7 µm)*
n=24 Participants
Fluticasone Propionate dry powder inhaler formulation 3 (C-3.7 µm)\* administered via Plastiape Monodose Dry powder Inhaler on Day 1 of study period, 500mcg single dose (administered as 5 capsules and each capsule was inhaled at least two times). \* (The asterisk) A different set of capsules from the same batch of formulation 3 is given to the subject to assess the within-subject variability and to ensure that the study is sufficiently powered to show bioequivalence between two replicates of the same formulation.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Profile From Time 0 the Last Quantifiable Concentration (AUC0-last) With Dose Normalization
|
658 pg.h/mL
Interval 585.0 to 740.0
|
700 pg.h/mL
Interval 622.0 to 787.0
|
716 pg.h/mL
Interval 636.0 to 805.0
|
748 pg.h/mL
Interval 665.0 to 841.0
|
PRIMARY outcome
Timeframe: Day 1 of Periods 1, 2, 3, and 4: pre-dose (15 minutes prior to the dosing), and 5, 10, 15, 20, 30, 45, 60 minutes, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours (+/- 1 hour) post-dosePopulation: PK population; N=number of participants contributing to the mean.
Cmax measured as picograms divided by milliliters (pg/mL) after pulmonary dose (estimated from anatomical throats) normalization.
Outcome measures
| Measure |
Fluticasone Propionate Formulation 1 (A-4.5 µm)
n=24 Participants
Fluticasone Propionate dry powder inhaler formulation 1 (A-4.5 µm) administered via Plastiape Monodose Dry powder Inhaler on Day 1 of study period, 500mcg single dose (administered as 5 capsules and each capsule was inhaled at least two times).
|
Fluticasone Propionate Formulation 2 (B-3.8 µm)
n=24 Participants
Fluticasone Propionate dry powder inhaler formulation 2 (B-3.8 µm) administered via Plastiape Monodose Dry powder Inhaler on Day 1 of study period, 500mcg single dose (administered as 5 capsules and each capsule was inhaled at least two times).
|
Fluticasone Propionate Formulation 3 (C-3.7 µm)
n=24 Participants
Fluticasone Propionate dry powder inhaler formulation 3 (C-3.7 µm) administered via Plastiape Monodose Dry powder Inhaler on Day 1 of study period, 500mcg single dose (administered as 5 capsules and each capsule was inhaled at least two times).
|
Fluticasone Propionate Formulation 3 (C-3.7 µm)*
n=24 Participants
Fluticasone Propionate dry powder inhaler formulation 3 (C-3.7 µm)\* administered via Plastiape Monodose Dry powder Inhaler on Day 1 of study period, 500mcg single dose (administered as 5 capsules and each capsule was inhaled at least two times). \* (The asterisk) A different set of capsules from the same batch of formulation 3 is given to the subject to assess the within-subject variability and to ensure that the study is sufficiently powered to show bioequivalence between two replicates of the same formulation.
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) With Dose Normalization
|
119 pg/mL
Interval 100.0 to 143.0
|
217 pg/mL
Interval 182.0 to 260.0
|
227 pg/mL
Interval 190.0 to 271.0
|
254 pg/mL
Interval 213.0 to 304.0
|
SECONDARY outcome
Timeframe: Day 1 of Periods 1, 2, 3, and 4: pre-dose (15 minutes prior to the dosing), and 5, 10, 15, 20, 30, 45, 60 minutes, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours (+/- 1 hour) post-dosePopulation: PK population; N=number of participants contributing to the mean.
Tmax measured as hours (h).
Outcome measures
| Measure |
Fluticasone Propionate Formulation 1 (A-4.5 µm)
n=24 Participants
Fluticasone Propionate dry powder inhaler formulation 1 (A-4.5 µm) administered via Plastiape Monodose Dry powder Inhaler on Day 1 of study period, 500mcg single dose (administered as 5 capsules and each capsule was inhaled at least two times).
|
Fluticasone Propionate Formulation 2 (B-3.8 µm)
n=24 Participants
Fluticasone Propionate dry powder inhaler formulation 2 (B-3.8 µm) administered via Plastiape Monodose Dry powder Inhaler on Day 1 of study period, 500mcg single dose (administered as 5 capsules and each capsule was inhaled at least two times).
|
Fluticasone Propionate Formulation 3 (C-3.7 µm)
n=24 Participants
Fluticasone Propionate dry powder inhaler formulation 3 (C-3.7 µm) administered via Plastiape Monodose Dry powder Inhaler on Day 1 of study period, 500mcg single dose (administered as 5 capsules and each capsule was inhaled at least two times).
|
Fluticasone Propionate Formulation 3 (C-3.7 µm)*
n=24 Participants
Fluticasone Propionate dry powder inhaler formulation 3 (C-3.7 µm)\* administered via Plastiape Monodose Dry powder Inhaler on Day 1 of study period, 500mcg single dose (administered as 5 capsules and each capsule was inhaled at least two times). \* (The asterisk) A different set of capsules from the same batch of formulation 3 is given to the subject to assess the within-subject variability and to ensure that the study is sufficiently powered to show bioequivalence between two replicates of the same formulation.
|
|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
0.51 h
Interval 0.18 to 1.6
|
0.33 h
Interval 0.17 to 1.1
|
0.30 h
Interval 0.17 to 1.08
|
0.27 h
Interval 0.17 to 1.1
|
SECONDARY outcome
Timeframe: Day 1 of Periods 1, 2, 3, and 4: pre-dose (15 minutes prior to the dosing), and 5, 10, 15, 20, 30, 45, 60 minutes, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours (+/- 1 hour) post-dosePopulation: PK population; N=number of participants contributing to the mean.
MRT measured as hours (h)
Outcome measures
| Measure |
Fluticasone Propionate Formulation 1 (A-4.5 µm)
n=24 Participants
Fluticasone Propionate dry powder inhaler formulation 1 (A-4.5 µm) administered via Plastiape Monodose Dry powder Inhaler on Day 1 of study period, 500mcg single dose (administered as 5 capsules and each capsule was inhaled at least two times).
|
Fluticasone Propionate Formulation 2 (B-3.8 µm)
n=24 Participants
Fluticasone Propionate dry powder inhaler formulation 2 (B-3.8 µm) administered via Plastiape Monodose Dry powder Inhaler on Day 1 of study period, 500mcg single dose (administered as 5 capsules and each capsule was inhaled at least two times).
|
Fluticasone Propionate Formulation 3 (C-3.7 µm)
n=24 Participants
Fluticasone Propionate dry powder inhaler formulation 3 (C-3.7 µm) administered via Plastiape Monodose Dry powder Inhaler on Day 1 of study period, 500mcg single dose (administered as 5 capsules and each capsule was inhaled at least two times).
|
Fluticasone Propionate Formulation 3 (C-3.7 µm)*
n=24 Participants
Fluticasone Propionate dry powder inhaler formulation 3 (C-3.7 µm)\* administered via Plastiape Monodose Dry powder Inhaler on Day 1 of study period, 500mcg single dose (administered as 5 capsules and each capsule was inhaled at least two times). \* (The asterisk) A different set of capsules from the same batch of formulation 3 is given to the subject to assess the within-subject variability and to ensure that the study is sufficiently powered to show bioequivalence between two replicates of the same formulation.
|
|---|---|---|---|---|
|
Mean Residence Time (MRT)
|
11.6 h
Interval 6.46 to 18.1
|
9.47 h
Interval 7.07 to 13.7
|
9.41 h
Interval 6.23 to 13.7
|
9.49 h
Interval 6.28 to 16.5
|
SECONDARY outcome
Timeframe: Day 1 of Periods 1, 2, 3, and 4: pre-dose (15 minutes prior to the dosing), and 5, 10, 15, 20, 30, 45, 60 minutes, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours (+/- 1 hour) post-dosePopulation: PK population; N=number of participants contributing to the mean.
t1/2 measured as hours (h)
Outcome measures
| Measure |
Fluticasone Propionate Formulation 1 (A-4.5 µm)
n=24 Participants
Fluticasone Propionate dry powder inhaler formulation 1 (A-4.5 µm) administered via Plastiape Monodose Dry powder Inhaler on Day 1 of study period, 500mcg single dose (administered as 5 capsules and each capsule was inhaled at least two times).
|
Fluticasone Propionate Formulation 2 (B-3.8 µm)
n=24 Participants
Fluticasone Propionate dry powder inhaler formulation 2 (B-3.8 µm) administered via Plastiape Monodose Dry powder Inhaler on Day 1 of study period, 500mcg single dose (administered as 5 capsules and each capsule was inhaled at least two times).
|
Fluticasone Propionate Formulation 3 (C-3.7 µm)
n=24 Participants
Fluticasone Propionate dry powder inhaler formulation 3 (C-3.7 µm) administered via Plastiape Monodose Dry powder Inhaler on Day 1 of study period, 500mcg single dose (administered as 5 capsules and each capsule was inhaled at least two times).
|
Fluticasone Propionate Formulation 3 (C-3.7 µm)*
n=24 Participants
Fluticasone Propionate dry powder inhaler formulation 3 (C-3.7 µm)\* administered via Plastiape Monodose Dry powder Inhaler on Day 1 of study period, 500mcg single dose (administered as 5 capsules and each capsule was inhaled at least two times). \* (The asterisk) A different set of capsules from the same batch of formulation 3 is given to the subject to assess the within-subject variability and to ensure that the study is sufficiently powered to show bioequivalence between two replicates of the same formulation.
|
|---|---|---|---|---|
|
Elimination Half Life (t1/2)
|
10.3 h
Interval 5.74 to 17.6
|
10.3 h
Interval 6.88 to 13.4
|
9.75 h
Interval 6.33 to 15.6
|
10.1 h
Interval 6.74 to 19.9
|
Adverse Events
Fluticasone Propionate Formulation 1
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Fluticasone Propionate Formulation 2
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Fluticasone Propionate Formulation 3
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Fluticasone Propionate Formulation 3*
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fluticasone Propionate Formulation 1
n=24 participants at risk
Fluticasone Propionate Drug formulation 1 administered via Plastiape Monodose Dry powder Inhaler , 500mcg single dose.
See Formulation Development in Detailed Description for details regarding differences in formulations
Fluticasone Propionate Formulation 1: Fluticasone Propionate dry powder inhaler Formulation 1
Fluticasone Propionate Formulation 2: Fluticasone Propionate dry powder inhaler Formulation 2
Fluticasone Propionate Formulation 3: Fluticasone Propionate dry powder inhaler Formulation 3
Fluticasone Propionate Formulation 3\*: Fluticasone Propionate dry powder inhaler Formulation 3\*
\*(The asterisk) A different set of capsules from the same batch of formulation 3 is given to the subject to assess the within-subject variability and to ensure that the study is sufficiently powered to show bioequivalence between two replicates of the same formulation.
|
Fluticasone Propionate Formulation 2
n=24 participants at risk
Fluticasone Propionate Drug formulation 2 administered via Plastiape Monodose Dry powder Inhaler , 500mcg single dose.
See Formulation Development in Detailed Description for details regarding differences in formulations
Fluticasone Propionate Formulation 1: Fluticasone Propionate dry powder inhaler Formulation 1
Fluticasone Propionate Formulation 2: Fluticasone Propionate dry powder inhaler Formulation 2
Fluticasone Propionate Formulation 3: Fluticasone Propionate dry powder inhaler Formulation 3
Fluticasone Propionate Formulation 3\*: Fluticasone Propionate dry powder inhaler Formulation 3\*
\*(The asterisk) A different set of capsules from the same batch of formulation 3 is given to the subject to assess the within-subject variability and to ensure that the study is sufficiently powered to show bioequivalence between two replicates of the same formulation.
|
Fluticasone Propionate Formulation 3
n=24 participants at risk
Fluticasone Propionate Drug formulation 3 administered via Plastiape Monodose Dry powder Inhaler , 500mcg single dose.
See Formulation Development in Detailed Description for details regarding differences in formulations
Fluticasone Propionate Formulation 1: Fluticasone Propionate dry powder inhaler Formulation 1
Fluticasone Propionate Formulation 2: Fluticasone Propionate dry powder inhaler Formulation 2
Fluticasone Propionate Formulation 3: Fluticasone Propionate dry powder inhaler Formulation 3
Fluticasone Propionate Formulation 3\*: Fluticasone Propionate dry powder inhaler Formulation 3\*
\*(The asterisk) A different set of capsules from the same batch of formulation 3 is given to the subject to assess the within-subject variability and to ensure that the study is sufficiently powered to show bioequivalence between two replicates of the same formulation.
|
Fluticasone Propionate Formulation 3*
n=24 participants at risk
Fluticasone Propionate Drug formulation 3 administered via Plastiape Monodose Dry powder Inhaler , 500mcg single dose. \*
Fluticasone Propionate Formulation 1: Fluticasone Propionate dry powder inhaler Formulation 1
Fluticasone Propionate Formulation 2: Fluticasone Propionate dry powder inhaler Formulation 2
Fluticasone Propionate Formulation 3: Fluticasone Propionate dry powder inhaler Formulation 3
Fluticasone Propionate Formulation 3\*: Fluticasone Propionate dry powder inhaler Formulation 3\*
\*(The asterisk) A different set of capsules from the same batch of formulation 3 is given to the subject to assess the within-subject variability and to ensure that the study is sufficiently powered to show bioequivalence between two replicates of the same formulation.
|
|---|---|---|---|---|
|
General disorders
Dry Throat
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
4.2%
1/24 • Number of events 1 • The duration of study participants is up to 2 months.
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
4.2%
1/24 • Number of events 1 • The duration of study participants is up to 2 months.
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 1 • The duration of study participants is up to 2 months.
|
8.3%
2/24 • Number of events 2 • The duration of study participants is up to 2 months.
|
4.2%
1/24 • Number of events 1 • The duration of study participants is up to 2 months.
|
8.3%
2/24 • Number of events 2 • The duration of study participants is up to 2 months.
|
|
Reproductive system and breast disorders
Menstrual Cramps/Pain
|
8.3%
2/24 • Number of events 2 • The duration of study participants is up to 2 months.
|
4.2%
1/24 • Number of events 1 • The duration of study participants is up to 2 months.
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.2%
1/24 • Number of events 1 • The duration of study participants is up to 2 months.
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
|
Infections and infestations
Running Nose/Dry Cough
|
4.2%
1/24 • Number of events 1 • The duration of study participants is up to 2 months.
|
4.2%
1/24 • Number of events 1 • The duration of study participants is up to 2 months.
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
|
Vascular disorders
Chest Discomfort
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
4.2%
1/24 • Number of events 1 • The duration of study participants is up to 2 months.
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
|
General disorders
Funny taste
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
4.2%
1/24 • Number of events 1 • The duration of study participants is up to 2 months.
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
|
General disorders
Nausea
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
4.2%
1/24 • Number of events 1 • The duration of study participants is up to 2 months.
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
|
Musculoskeletal and connective tissue disorders
Injuries after fall/accident
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
12.5%
3/24 • Number of events 3 • The duration of study participants is up to 2 months.
|
4.2%
1/24 • Number of events 1 • The duration of study participants is up to 2 months.
|
|
General disorders
Dizziness/ Lightheadedness
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
8.3%
2/24 • Number of events 2 • The duration of study participants is up to 2 months.
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
|
Skin and subcutaneous tissue disorders
Skin redness
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
0.00%
0/24 • The duration of study participants is up to 2 months.
|
4.2%
1/24 • Number of events 1 • The duration of study participants is up to 2 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place