NCT05021887

A Bioequivalence Study Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 100 mcg/Blister Oral Inhalation Powder /GSK in Healthy Volunteers Under Fasting Conditions

A Randomized, Single-dose, Open Label, Two-treatment, Two-sequence, Two-period, Crossover Study Under Fasting Conditions to Examine the Bioequivalence Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 100 mcg/Blister Oral Inhalation Powder /GSK in Healthy Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Respirent Pharmaceuticals Co Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Bioequivalence study between two inhaler products of ffluticasone propionate inhalation powder

Detailed description

A bioequivalence study of a single dose of Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 100 mcg/Blister Oral Inhalation Powder /GSK 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

• Asthma
• Bioequivalence

Interventions

Type	Name	Description
DRUG	Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals	2 inhalations of Test and Reference product in each study period
DRUG	FLOVENT DISKUS	2 inhalations of Test and Reference product in each study period

Timeline

• Start date: 2021-08-13
• Primary completion: 2021-09-30
• Completion: 2021-11-30
• First posted: 2021-08-26
• Last updated: 2021-08-26

Locations

1 site across 1 country: Greece

Regulatory

• FDA-regulated drug study