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Sponsored by: |
Teva Pharmaceuticals USA |
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Information provided by: | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00835081 |
The objective of this study is to compare the relative bioavailability of cefadroxil 500 mg capsules (manufactured by Teva Pharmaceuticals USA) with that of DURICEF® 500 mg capsules (manufactured by Bristol-Myers Squibb Company) when dosed (1 x 500 mg capsules) in normal healthy non-smoking male and female subjects under fed conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Cefadroxil 500 mg Capsules Drug: DURICEF® capsules 500 mg |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Two-Way , Crossover, Open-Label, Single-Dose, Fed, Bioequivalence Study of Cefadroxil 500 mg Capsules Versus DURICEF® 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects. |
Enrollment: | 26 |
Study Start Date: | September 2004 |
Study Completion Date: | October 2004 |
Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Cefadroxil 500 mg Capsules
1 x 500 mg
|
2: Active Comparator |
Drug: DURICEF® capsules 500 mg
1 x 500 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, Texas | |
Bioassay Laboratory, Inc. | |
Houston, Texas, United States, 77099 | |
Canada, Ontario | |
Biovail Contract Research | |
Toronto, Ontario, Canada, M1L 4R6 |
Principal Investigator: | Paul Y Tam, M.D. | Biovail Contract Research |
Study ID Numbers: | 2921 |
Study First Received: | January 30, 2009 |
Last Updated: | January 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00835081 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Bioequivalence Healthy Subjects |
Anti-Bacterial Agents Cefadroxil Healthy |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Cefadroxil Pharmacologic Actions |