NCT04564456View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

September 22, 2020

Primary Completion Date

October 31, 2020

Study Completion Date

December 31, 2020

Conditions
Bioequivalence
Interventions
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

Trial Locations (1)

41100

BECRO Clinical Facility, Larissa

All Listed Sponsors
collaborator

Becro Ltd.

INDUSTRY

lead

Respirent Pharmaceuticals Co Ltd.

INDUSTRY

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 | Biotech Hunter | Biotech Hunter