Single Dose Study of the Fluticasone/Salmeterol (500/50 μg) Administered With Elpenhaler® Versus Diskus®
Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
Participant gender:
Summary
The aim of this study is to establish the therapeutic equivalence between the test
(Fluticasone/Salmeterol administered with Elpenhaler®, Rolenium®) and the reference
formulation (Seretide®, administered with Diskus®), both containing 500/50μg of the
Fluticasone/Salmeterol combination.
The study will be conducted in a randomized, double-blind, double-dummy, 2x2 crossover
fashion.
Phase:
Phase 3
Details
Lead Sponsor:
Elpen Pharmaceutical Co. Inc.
Treatments:
Fluticasone Fluticasone Propionate, Salmeterol Xinafoate Drug Combination Salmeterol Xinafoate