NCT01286701

Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Under Fed Conditions

Randomized, 2-way Crossover Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg and Lamisil® 250 mg Tablets in Healthy Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the rate and extent of absorption of terbinafine hydrochloride 250 mg tablets versus Lamisil® 250 mg tablets administered as 1 x 250 mg tablet under fed conditions.

Detailed description

Randomized, 2-way crossover, bioequivalence study of Terbinafine hydrochloride 250 mg tablets and Lamisil® 250 mg Tablets administered as 1 x 250 mg tablet in healthy subjects under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Terbinafine Hydrochloride Tablets, 250 mg	Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Laboratories Limited.

Timeline

• Start date: 2002-01-01
• Primary completion: 2002-02-01
• Completion: 2002-03-01
• First posted: 2011-01-31
• Last updated: 2012-01-11

Locations

1 site across 1 country: Canada