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Bioequivalence study between two inhaler products (discus) of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
Full description
A bioequivalence study of a single dose of the fixed-dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder administered from Fluticasone propionate 100 mcg and Salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals (test-Τ) as 2 inhalations and SERETIDE DISKUS® 100/50 mcg inhalation powder/GSK (reference-R) in healthy volunteers under fasting conditions with charcoal blockade. The study will be one-center crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded.
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Inability to abstain from alcohol for the duration of study period.
Reliable contraception methods are considered the following:
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Interventional model
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36 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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