Bioequivalence of RYTHMOL SR® Manufactured at Two Different Sites

Arrhythmia, Cardiac Clinical Trial

Official title: A Phase 1, Open-Label, Crossover Study to Demonstrate the Bioequivalence of RYTHMOL SR® (Propafenone Hydrochloride) Manufactured at Two Different Sites

Status Completed

Clinical Trial Summary

Bioequivalence of propafenone hydrochloride capsules manufactured at two different sites

Clinical Trial Description

This will be a Phase 1, randomized, open-label, single-dose, three-period, crossover study to assess the bioequivalence of propafenone hydrochloride manufactured at two different sites in healthy adult volunteers. Approximately 36 subjects will receive a 3 single doses of propafenone hydrochloride 425mg, each administered separately, in the fasted state with a 7 day washout period between doses. Propafenone hydrochloride is an antiarrhythmic indicated to prolong the time to recurrence of symptomatic atrial fibrillation in patients with episodic (most likely paroxysmal or persistent) atrial fibrillation who do not have structural heart disease. A follow-up visit will occur 7-10 days after the final dose of study drug. ;

Related Conditions & MeSH terms

• Arrhythmia, Cardiac
• Arrhythmias, Cardiac

• NCT number: NCT01956487
• Study type: Interventional
• Source: GlaxoSmithKline
• Status: Completed
• Phase: Phase 1
• Start date: April 11, 2012
• Completion date: June 27, 2012