NCT00647647

Fasting Study of Terbinafine Hydrochloride Tablets 250 mg and Lamisil® Tablets 250 mg

Single-Dose Fasting In Vivo Bioequivalence Study of Terbinafine Hydrochloride Tablets (250 mg; Mylan) to Lamisil® Tablets (250 mg; Novartis) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to investigate the bioequivalence of Mylan's terbinafine hydrochloride 250 mg tablets to Novartis' Lamisil® 250 mg tablets following a single, oral 250 mg (1 x 250 mg) dose administered under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Terbinafine Hydrochloride Tablets 250 mg	250mg, single dose fasting
DRUG	Lamisil® Tablets 250 mg	250mg, single dose fasting

Timeline

• Start date: 2004-02-01
• Primary completion: 2004-03-01
• Completion: 2004-03-01
• First posted: 2008-04-01
• Last updated: 2024-04-23

Locations

1 site across 1 country: United States