NCT04564456

A Pivotal Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers

A Pivotal, Randomized, Single-dose, Open Label, Two-treatment, Two-sequence, Two-period, Crossover Study Under Fasting Conditions to Examine the Bioequivalence Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (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 500 mcg and Salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals (test-Τ) as 2 inhalations and ADVAIR DISKUS® 500/50 mcg inhalation powder/GSK (reference-R) in healthy volunteers under fasting conditions. 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 500 mcg and salmeterol xinafoate 50 mcg/Respirent	2 inhalations of Test oproduct in one study period
DRUG	ADVAIR DISKUS® 500/50	2 inhalations Reference product in one study period

Timeline

• Start date: 2020-09-22
• Primary completion: 2020-10-31
• Completion: 2020-12-31
• First posted: 2020-09-25
• Last updated: 2021-01-20

Locations

1 site across 1 country: Greece

Regulatory

• FDA-regulated drug study