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Sponsored by: |
Teva Pharmaceuticals USA |
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Information provided by: | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00835354 |
The objective of this study is to compare the relative bioavailability of cefprozil for oral suspension 250 mg/5 mL (TEVA Pharmaceuticals USA) with that of CEFZIL® for Oral Suspension 250 mg/5 mL (Bristol-Myers Squibb) in healthy, non-smoking adults under non-fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Cefprozil for oral suspension 250 mg/5 mL Drug: CEFZIL® for Oral Suspension 250 mg/5mL |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Relative Bioavailability Study of Cefprozil for Oral Suspension 250 mg/5 mL Under Non-Fasting Conditions |
Enrollment: | 26 |
Study Start Date: | May 2004 |
Study Completion Date: | May 2004 |
Primary Completion Date: | May 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Cefprozil for oral suspension 250 mg/5 mL
1 x 250 mg/5 mL, single-dose fasting
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2: Active Comparator |
Drug: CEFZIL® for Oral Suspension 250 mg/5mL
1 x 250 mg/5 mL, single-dose fasting
|
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:
Clinical laboratory measurements will include the following:
Exclusion Criteria:
United States, Missouri | |
Gateway Medical Research, Inc. | |
St. Charles, Missouri, United States, 63301 | |
United States, Texas | |
Bioassay Laboratory, Inc. | |
Houston, Texas, United States, 77099 |
Principal Investigator: | Steven Herrmann, M.D. | Cetero Research |
Study ID Numbers: | B036559 |
Study First Received: | January 30, 2009 |
Last Updated: | January 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00835354 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bioequivalence Healthy Subjects |
Anti-Bacterial Agents Cefprozil Healthy |
Anti-Infective Agents Anti-Bacterial Agents Cefprozil Therapeutic Uses Pharmacologic Actions |