NCT00833664

Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions

The Relative Bioavailability of Two Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The Purpose of this study os to evaluate the relative bioavailability of the test formulation of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis Pharmaceuticals), under post-prandial conditions in healthy, non-tobacco using male and female adult subjects.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Terbinafine HCl 250mg tablets	1 x 250 mg
DRUG	Lamisil® 250 mg Tablets	1 x 250 mg

Timeline

• Start date: 2002-01-01
• Primary completion: 2002-01-01
• Completion: 2002-01-01
• First posted: 2009-02-02
• Last updated: 2023-05-30
• Results posted: 2009-08-18

Locations

1 site across 1 country: United States