Mycoses Clinical Trial - Bioequivalence Study for Terbinafine 250 mg

Status Completed

Clinical Trial Summary

The objective of this study was to confirm if two formulations of terbinafine (tablets) are bioequivalent.

Test product was Xilatril® 250 mg (Laboratorios Dermatológicos Darier) and reference product Lamisil® 250 mg (Novartis). One tablet was the single dosage.

The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions.

The population was composed of 30 healthy volunteers, both genders, adults between 18-50 years.

The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Mycoses

Clinical Trial Details

NCT number	NCT01772212
Study type	Interventional
Source	GlaxoSmithKline
Contact
Status	Completed
Phase	Phase 1
Start date	February 24, 2011
Completion date	March 15, 2011

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