Bioequivalence Study for Terbinafine 250 mg

Study Overview
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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.

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

Conditions
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Mycoses

Intervention / Treatment
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* Drug: Terbinafine 250 mg
* Drug: Terbinafine 250 mg


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A(test)/B(reference)<br>Initial administration of test and crossover to reference | Drug: Terbinafine 250 mg<br>* Test product<br>* Other names: Xilatril® is a registered trademark of Laboratorios Dermatológicos Darier;Drug: Terbinafine 250 mg<br>* Reference product<br>* Other names: Lamisil® is a registered trademark of Novartis;|
| Experimental: B(reference)/A(test)<br>Initial administration of reference and crossover to test | Drug: Terbinafine 250 mg<br>* Test product<br>* Other names: Xilatril® is a registered trademark of Laboratorios Dermatológicos Darier;Drug: Terbinafine 250 mg<br>* Reference product<br>* Other names: Lamisil® is a registered trademark of Novartis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (CMAX) of drug terbinafine | pharmacokinetics | 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 | 
| Area under the plasma concentration versus time curve (AUC) of drug terbinafine | pharmacokinetics | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mexico, terbinafine, mycoses, pharmacokinetics