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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Fluticasone propionate and salmeterol xinafoate combination as a dry powder inhaler for oral inhalation with unit dose strength of 100/50 mcg (available in blister pack) administered via DISKUS (Ddpi) device.
Fluticasone propionate and salmeterol xinafoate combination as a dry powder inhaler for oral inhalation with unit dose strength of 100/50 mcg (available in blister pack) administered via ROTAHALER (Rdpi) device.
GSK Investigational Site
Randwick, New South Wales, Australia
Composite of PK parameters of FSC delivered via the Rdpi relative to FSC delivered via the Ddpi
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).
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.
Composite of PK parameters of FSC delivered via the Rdpi relative to FSC delivered via the Ddpi
PK Parameters include: area under the plasma salmeterol concentration-time curve over dosing interval (AUCtau), fluticasone propionate maximum plasma concentration-time curve on the last day of each study treatment period (Cmax), and fluticasone propionate and salmeterol time of occurence of Cmax (Tmax) on the last day of each treatment period (Day 4).
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.
Number of participants with adverse events (AEs) as measure of safety and tolerability.
AEs will be collected from the start of study treatment and until the follow-up contact.
Time frame: 35 days.
Laboratory parameters as a measure of safety and tolerability.
Laboratory parameters include: hematology, clinical chemistry, urinalysis and additional parameters.
Time frame: 35 days
Vital sign measurement as measure of safety and tolerability.
Vital parameters include: systolic blood pressure, diastolic blood pressure, and pulse rate.
Time frame: 35 days.
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