NCT04124094View on ClinicalTrials.gov

A Bioequivalence Study Between Fluticasone and Salmeterol vs. SERETIDE DISKUS® in Healthy Volunteers With Charcoal Blockade

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

October 1, 2019

Primary Completion Date

October 25, 2019

Study Completion Date

June 9, 2020

Conditions
Bioequivalence
Interventions
DRUG

Test Product (Fluticasone propionate and salmeterol xinafoate inhalation powder/Respirent Pharmaceuticals)

Fluticasone propionate 100 mcg and salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals

DRUG

Reference Product (SERETIDE DISKUS® 100/50 inhalation powder/GSK)

2 inhalations in one study period

OTHER

Activated Charcoal suspension

oral suspension before and after inhalation of study Investigational Products

Trial Locations (1)

41100

BECRO Clinical Facility, Larissa

All Listed Sponsors
collaborator

Becro Ltd.

INDUSTRY

lead

Respirent Pharmaceuticals Co Ltd.

INDUSTRY

NCT04124094 - A Bioequivalence Study Between Fluticasone and Salmeterol vs. SERETIDE DISKUS® in Healthy Volunteers With Charcoal Blockade | Biotech Hunter | Biotech Hunter