Single Dose Study of the Fluticasone/Salmeterol (500/50 μg) Administered With Elpenhaler® Versus Diskus®

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.

Timeline

Start

2008-03

Primary completion

2008-08

Completion

2008-10

Drugs

Indications