NCT01956487

Bioequivalence of RYTHMOL SR® Manufactured at Two Different Sites

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Bioequivalence of propafenone hydrochloride capsules manufactured at two different sites

Detailed 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.

Conditions

• Arrhythmia, Cardiac

Interventions

Type	Name	Description
DRUG	Propafenone	Comparison of drug from 2 manufacturing sites

Timeline

• Start date: 2012-04-11
• Primary completion: 2012-06-27
• Completion: 2012-06-27
• First posted: 2013-10-08
• Last updated: 2017-06-12

Locations

1 site across 1 country: United States