NCT03915340View on ClinicalTrials.gov

Bioequivalence Study of Two Formulations of Propafenone 300 mg Film-coated Tablets in Healthy Adult Volunteers After a Single Oral Dose Administration Under Fasting Conditions

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

March 23, 2019

Primary Completion Date

May 8, 2019

Study Completion Date

May 8, 2019

Conditions
Bioequivalence
Interventions
DRUG

Propafenone

Propafenone is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 300 mg of propafenone hydrochloride.

DRUG

Rytmonorm

Rytmonorm is manufactured by Famar Lyon, France (MAH: Mylan Healthcare GmbH, Germany). Each tablet contains 300 mg of propafenone hydrochloride.

Trial Locations (1)

H3P 3P1

Altasciences Company Inc., Mount Royal

All Listed Sponsors
collaborator

Altasciences Company Inc.

INDUSTRY

lead

Pharmtechnology LLC

INDUSTRY

NCT03915340 - Bioequivalence Study of Two Formulations of Propafenone 300 mg Film-coated Tablets in Healthy Adult Volunteers After a Single Oral Dose Administration Under Fasting Conditions | Biotech Hunter | Biotech Hunter