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Sponsored by: |
Teva Pharmaceuticals USA |
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Information provided by: | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00833664 |
The Purpose of this study os to evaluate the relative bioavailability of the test formulation of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis Pharmaceuticals), under post-prandial conditions in healthy, non-tobacco using male and female adult subjects.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Terbinafine HCl 250mg tablets Drug: Lamisil® 250 mg Tablets |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | The Relative Bioavailability of Two Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions |
Enrollment: | 22 |
Study Start Date: | January 2002 |
Study Completion Date: | January 2002 |
Primary Completion Date: | January 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Terbinafine: Experimental
Terbinafine 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period
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Drug: Terbinafine HCl 250mg tablets
1 x 250 mg
|
Lamisil®: Active Comparator
Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
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Drug: Lamisil® 250 mg Tablets
1 x 250 mg
|
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Novum Pharmaceutical Research Services | |
Pittsburg, Pennsylvania, United States, 15206-3817 |
Principal Investigator: | Shirley Ann Kennedy, M.D. | Novum |
Study ID Numbers: | 10136025 |
Study First Received: | January 30, 2009 |
Results First Received: | July 6, 2009 |
Last Updated: | July 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00833664 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bioequivalence Healthy Subjects |
Anti-Infective Agents Antifungal Agents Healthy Terbinafine |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antifungal Agents |
Enzyme Inhibitors Pharmacologic Actions Terbinafine |