NCT03602300View on ClinicalTrials.gov

A Phase 1 Bioequivalence Study of a Test Tablet Formulation of Ravidasvir With the Reference Tablet Formulation of Ravidasvir Study

PHASE1CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

June 5, 2018

Primary Completion Date

August 17, 2018

Study Completion Date

August 17, 2018

Conditions
Bioequivalence Study
Interventions
DRUG

Ravidasvir test formulation produced by Doppel

"To compare the rate and extent of absorption for RDV when administered as a single 200 mg oral dose of the proposed commercial product (test) produced by Doppel Farmaceutici with the clinical trial product (reference) manufactured by EEPI in healthy volunteers, under fasted conditions."

DRUG

Ravidasvir reference formulation produced by EEPI

"To compare the rate and extent of absorption for RDV when administered as a single 200 mg oral dose of the proposed commercial product (test) produced by Doppel Farmaceutici with the clinical trial product (reference) manufactured by EEPI in healthy volunteers, under fasted conditions."

Trial Locations (1)

68000

Ampang hospital, Ampang

All Listed Sponsors
lead

Drugs for Neglected Diseases

OTHER

NCT03602300 - A Phase 1 Bioequivalence Study of a Test Tablet Formulation of Ravidasvir With the Reference Tablet Formulation of Ravidasvir Study | Biotech Hunter | Biotech Hunter