Bioequivalence study of Flecainide 100mg tablet of Vana Darou Gostar Pharm Co., IRA

Not Applicable

• Conditions: Cardiac arrhythmia.; Cardiac arrhythmia, unspecified; I49.9

• Registration Number: IRCT20190706044111N23
• Lead Sponsor: Vana Darou Gostar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Aged between 18 - 50 years
- Body weight between 50 – 100 kg
- Having good health on the basis of medical history and physical & clinical examination
- Understand the procedures and give written informed consent

Exclusion Criteria

Subject had undergone surgery of the gastro-intestinal tract
Subject had donated a unit of blood or participated in another clinical trial, within the last two months before the first treatment.
Subject had a history of drug or alcohol abuse.
Subject who smokes more than 10 cigarettes per day.
Subject had used any prescription medication within 14 days, or any non-prescription medication within 7 days, before the first treatment.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma concentration of Flecainide. Timepoint: 0 (before dosing), 1.0, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 24.0 & 48.0 hr. after dosing. Method of measurement: Using High Performance Liquid Chromatography (HPLC).