Clinical Trials Directory

Trials / Completed

CompletedNCT00602342

Bioequivalency Study of Terbinafine Tablets Under Fasting Conditions

A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 250 mg Terbinafine Hydrochloride Tablets Under Fasting Conditions

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Roxane Laboratories · Industry
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Accepted

Summary

The objective of this study was the bioequivalence of a Roxane Laboratories' terbinafine tablets, 250 mg, to Lamisil® Tablets, 250 mg (Novartis Pharmaceutical Corporation.) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Conditions

Interventions

TypeNameDescription
DRUGTerbinafine

Timeline

Start date
2004-03-01
Primary completion
2004-04-01
Completion
2004-04-01
First posted
2008-01-28
Last updated
2018-01-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00602342. Inclusion in this directory is not an endorsement.