NCT03894280

A Bioequivalence Study Between Fluticasone Salmeterol Xinafoate vs. SERETIDE DISKUS® in Healthy Volunteers With Charcoal Blockade (BREATH-PK250-CC)

A Randomized, Single-dose, Open Label, Two-treatment, Two-sequence, Two-period, Crossover Study to Examine the Bioequivalence Between Fluticasone Propionate 250 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. SERETIDE DISKUS® 250/50 Inhalation Powder/GSK in Healthy Volunteers Under Fasting Conditions With Charcoal Blockade

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Respirent Pharmaceuticals Co Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder

Detailed 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 250 mcg and Salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals (test-Τ) as 2 inhalations and SERETIDE DISKUS® 250/50 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.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Fluticasone propionate 250 mcg and salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals	2 inhalations in one study period
DRUG	SERETIDE DISKUS® 250/50 inhalation powder/GSK	2 inhalations in one study period
OTHER	Activated Charcoal suspension	oral suspension before and after inhalation of study Investigational Products

Timeline

• Start date: 2019-03-12
• Primary completion: 2019-04-09
• Completion: 2019-05-06
• First posted: 2019-03-28
• Last updated: 2019-06-05

Locations

1 site across 1 country: Greece