Terbinafine HCl 250 mg Tablet Under Fasting Conditions

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the relative bioavailability of the test formulation of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis Pharmaceuticals), under fasted conditions in healthy, non-tobacco using male and female adult subjects.

Detailed Description
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Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Official Title
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The Relative Bioavailability of Two Terbinafine HCl 250 mg Tablet Formulations Under Fasting Conditions

Conditions
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Healthy

Intervention / Treatment
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* Drug: Terbinafine HCl 250mg tablets
* Drug: Lamisil® 250 mg Tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females, 18 years or older inclusive with a body mass index (BMI) of 30 or less. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening. Signed and dated informed consent form, which meets all criteria of current FDA regulations If female and of child bearing potential subjects must be prepared to abstain from sexual intercourse or use a reliable barrier method of contraception (e.g. condom, IUD) during the duration of the study. Female subjects who have used oral contraceptives within 14 days or injected hormonal contraceptives within 180 days of dosing will not be allowed to participate. Exclusion Criteria: If female, pregnant, lactating or likely to become pregnant during the study. History of allergy or sensitivity to terbinafine, or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study. Significant history or current evidence of chronic evidence of chronic infectious disease, system disorder ot organ dysfunction. Presence of gastrointestinal disease ot history of malabsorption within the last year. History of psychiatric disorders occuring within the last two years that required hospitalization or medication. Presence of a medical condition requiring regular treatment with prescription drugs. Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes. within 30 days prior to dosing. Receipt of any drug as part of a research study within 30 days prior to dosing. Drug or alcohol addition requiring treatment in the past 12 months. Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma within 14 days prior to dosing. Positive test results for drug of abuse at screening. Tobacco user within 90 days of the first study dose. Unable, or unwilling to tolerate multiple venipunctures.

Ages Eligible for Study
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Minimum Age: 18 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Terbinafine<br>Terbinafine HCl 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period | Drug: Terbinafine HCl 250mg tablets<br>* 1 x 250 mg<br>|
| Active Comparator: Lamisil®<br>Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period | Drug: Lamisil® 250 mg Tablets<br>* 1 x 250 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax - Maximum Observed Concentration - Terbinafine in Plasma | Bioequivalence based on Cmax | Blood samples collected over 144 hour period | 
| AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Terbinafine in Plasma | Bioequivalence based on AUC0-inf | Blood samples collected over 144 hour period | 
| AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Terbinafine in Plasma | Bioequivalence based on AUC0-t | Blood samples collected over 144 hour period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Healthy Subjects