Bioequivalence Study for Terbinafine 250 mg

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT01772212

Collaborator

(none)

Enrollment

Arms

Actual Duration (Days)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Mycoses	Drug: Terbinafine 250 mg Drug: Terbinafine 250 mg	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Bioequivalence Study Between Two Medications for the Oral Administration of Terbinafine 250 mg in Oral Solids in Healthy Volunteers

Actual Study Start Date :

Feb 24, 2011

Actual Primary Completion Date :

Mar 15, 2011

Actual Study Completion Date :

Mar 15, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A(test)/B(reference) Initial administration of test and crossover to reference	Drug: Terbinafine 250 mg Test product Other Names: Xilatril® is a registered trademark of Laboratorios Dermatológicos Darier Drug: Terbinafine 250 mg Reference product Other Names: Lamisil® is a registered trademark of Novartis
Experimental: B(reference)/A(test) Initial administration of reference and crossover to test	Drug: Terbinafine 250 mg Test product Other Names: Xilatril® is a registered trademark of Laboratorios Dermatológicos Darier Drug: Terbinafine 250 mg Reference product Other Names: Lamisil® is a registered trademark of Novartis

Arm

Intervention/Treatment

Experimental: A(test)/B(reference)

Initial administration of test and crossover to reference

Drug: Terbinafine 250 mg

Test product

Other Names:

Xilatril® is a registered trademark of Laboratorios Dermatológicos Darier

Drug: Terbinafine 250 mg

Reference product

Other Names:

Lamisil® is a registered trademark of Novartis

Experimental: B(reference)/A(test)

Initial administration of reference and crossover to test

Drug: Terbinafine 250 mg

Test product

Other Names:

Xilatril® is a registered trademark of Laboratorios Dermatológicos Darier

Drug: Terbinafine 250 mg

Reference product

Other Names:

Lamisil® is a registered trademark of Novartis

Outcome Measures

Primary Outcome Measures

Peak Plasma Concentration (CMAX) of drug terbinafine [0.0, 0.33, 0.66, 1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, and 24.0 hours post dose]
pharmacokinetics
Area under the plasma concentration versus time curve (AUC) of drug terbinafine [0.0, 0.33, 0.66, 1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, and 24.0 hours post dose]
pharmacokinetics

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Inclusion Criteria: Males 18-50 years. Healthy based on comprehensive medical history, lab tests, Chest x-ray, Electrocardiogram, negative tests for Hepatitis B and C, and HIV. Negative urine doping test. BMI 19-26.5 kg/m2. Lab test in normal range +/- 10%. Blood pressure 139-90/89-50, heart rate 100-55, respiratory rate 24-17, temperature 37.5-35 °C. Non-smoking at least for 10 hrs before study. Written informed consent. -

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.