An Open-Label, Randomised, Two Treatment, Four-Way Cross-Over (Replicate Design), Two Sequence, Repeat Dose, Single Centre Study in Healthy Volunteers to Compare the Pharmacokinetics of Fluticasone Propionate/Salmeterol (100/50 mcg) Delivered Via the Low Airflow Resistance ROTAHALER Inhaler Relative to Fluticasone Propionate/Salmeterol (100/50 mcg) Delivered Via the DISKUS Inhaler
Overview
- Phase
- Phase 1
- Intervention
- Fluticasone Propionate / Salmeterol Xinafoate DISKUS
- Conditions
- Asthma
- Sponsor
- GlaxoSmithKline
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Composite of PK parameters of FSC delivered via the Rdpi relative to FSC delivered via the Ddpi
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study will compare the pharmacokinetic (PK) of Fluticasone Propionate/Salmeterol combination (FSC) 100/50 micrograms (mcg) delivered via the capsule-based inhaler (Rdpi) relative to FSC 100/50 mcg delivered via the multi-dose dry powder inhaler (Ddpi) to establish whether the Rdpi inhaler has exposure (in terms of fluticasone propionate area under time concentration curve [AUC] and Salmeterol maximum concentration [Cmax]) no greater than 1.2500 compared to the Ddpi, sufficient to allow progression to Phase 3. This study will enroll 36 healthy adult male and female subjects and each subject will be allocated to one of two sequences and will participate in four treatment periods, receiving each of the treatments twice.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Sequence 1
Subjects will receive treatment A and B in following sequence in four treatment periods (one treatment per period): ABBA, where treatment A is 7 doses of FSC (100/50 mcg) delivered via the Ddpi and treatment B is 7 doses of FSC (100/50mcg) delivered via the Rdpi. Subjects will be dosed twice daily for 3 days and once on the fourth day in the morning (a single inhalation of 100/50mcg per dose).
Intervention: Fluticasone Propionate / Salmeterol Xinafoate DISKUS
Sequence 1
Subjects will receive treatment A and B in following sequence in four treatment periods (one treatment per period): ABBA, where treatment A is 7 doses of FSC (100/50 mcg) delivered via the Ddpi and treatment B is 7 doses of FSC (100/50mcg) delivered via the Rdpi. Subjects will be dosed twice daily for 3 days and once on the fourth day in the morning (a single inhalation of 100/50mcg per dose).
Intervention: Fluticasone Propionate / Salmeterol Xinafoate ROTACAP
Sequence 2
Subjects will receive treatment A and B in following sequence in four treatment periods (one treatment per period): BAAB, where treatment A is 7 doses of FSC (100/50 mcg) delivered via the Ddpi and treatment B is 7 doses of FSC (100/50mcg) delivered via the Rdpi. Subjects will be dosed twice daily for 3 days and once on the fourth day in the morning (a single inhalation of 100/50mcg per dose).
Intervention: Fluticasone Propionate / Salmeterol Xinafoate DISKUS
Sequence 2
Subjects will receive treatment A and B in following sequence in four treatment periods (one treatment per period): BAAB, where treatment A is 7 doses of FSC (100/50 mcg) delivered via the Ddpi and treatment B is 7 doses of FSC (100/50mcg) delivered via the Rdpi. Subjects will be dosed twice daily for 3 days and once on the fourth day in the morning (a single inhalation of 100/50mcg per dose).
Intervention: Fluticasone Propionate / Salmeterol Xinafoate ROTACAP
Outcomes
Primary Outcomes
Composite of PK parameters of FSC delivered via the Rdpi relative to FSC delivered via the Ddpi
Time Frame: PK samples will be collected at pre-dose, 5 minutes (mins), 10 mins, 30 mins, 1, 2, 4, 8, 10, and 12 hours post dose on Day 4 of each treatment period.
PK Parameters include: area under the plasma fluticasone propionate concentration-time curve over dosing interval (AUCtau), salmeterol maximum plasma concentration-time curve on the last day of each study treatment period (Cmax).
Secondary Outcomes
- Vital sign measurement as measure of safety and tolerability.(35 days.)
- Composite of PK parameters of FSC delivered via the Rdpi relative to FSC delivered via the Ddpi(PK samples will be collected at pre-dose, 5 minutes (mins), 10 mins, 30 mins, 1, 2, 4, 8, 10, and 12 hours post dose on Day 4 of each treatment period.)
- Number of participants with adverse events (AEs) as measure of safety and tolerability.(35 days.)
- Laboratory parameters as a measure of safety and tolerability.(35 days)