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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

NCT03915340 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-06-06

No results posted yet for this study

Summary

This bioequivalence study will be conducted in healthy male and female volunteers in order to determine the bioequivalence of two different formulations of propafenone after a single oral dose administration under fasting conditions.

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.

Sponsors & Collaborators

  • Altasciences Company Inc.

    collaborator INDUSTRY

  • Pharmtechnology LLC

    lead INDUSTRY

Principal Investigators

  • Eric Sicard, MD · Altasciences Company Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-23
Primary Completion
2019-05-08
Completion
2019-05-08

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03915340 on ClinicalTrials.gov