NCT03894280View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

March 12, 2019

Primary Completion Date

April 9, 2019

Study Completion Date

May 6, 2019

Conditions

Bioequivalence

Interventions

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

Trial Locations (1)

41100

BECRO Clinical Facility, Larissa

All Listed Sponsors

collaborator

Becro Ltd.

INDUSTRY

lead

Respirent Pharmaceuticals Co Ltd.

INDUSTRY

NCT03894280 - A Bioequivalence Study Between Fluticasone Salmeterol Xinafoate vs. SERETIDE DISKUS® in Healthy Volunteers With Charcoal Blockade (BREATH-PK250-CC) | Biotech Hunter | Biotech Hunter