Bioequivalence Study for Terbinafine 250 mg

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-24

Study Completion Date

2011-03-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Mycoses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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A(test)/B(reference)

Initial administration of test and crossover to reference

Group Type EXPERIMENTAL

Terbinafine 250 mg

Intervention Type DRUG

Test product

Terbinafine 250 mg

Intervention Type DRUG

Reference product

B(reference)/A(test)

Initial administration of reference and crossover to test

Group Type EXPERIMENTAL

Terbinafine 250 mg

Intervention Type DRUG

Test product

Terbinafine 250 mg

Intervention Type DRUG

Reference product

Interventions

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Terbinafine 250 mg

Test product

Intervention Type DRUG

Terbinafine 250 mg

Reference product

Intervention Type DRUG

Other Intervention Names

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Xilatril® is a registered trademark of Laboratorios Dermatológicos Darier Lamisil® is a registered trademark of Novartis

Eligibility Criteria

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Exclusion Criteria

Hypersensitivity to study medication or other related drug. History of cardiovascular, renal, hepatic, metabolic, gastrointestinal, neurologic, endocrine, hematopoietic, psychiatric or organic condition.

Requiring any drug interfering with minocycline pharmacokinetics. Exposed to inducers or inhibitors of hepatic enzymes. Intake of possible toxic drugs 30 days before study. Intake of any drug 14 days or 7 half-lives before study. Hospitalization or severe disease 60 days before study. Receiving investigational drug out of study center 30 days before study. Blood loss or blood donation =\>450 ml 60 days before study. Recent history of drug abuse including alcohol. Intake of xanthine containing products 10 hrs before study. Intake of grapefruit juice or hot-spice 10 hrs before study.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes