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Sponsored by: |
Sandoz Inc. |
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Information provided by: | Sandoz Inc. |
ClinicalTrials.gov Identifier: | NCT00881855 |
The purpose of this study is to Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fed Conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Cefprozil 500 mg Tablets (Sandoz, GmbH) Drug: Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb, USA) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Sandoz GmbH and Bristol-Myers Squibb (Cefzil) 500 mg Cefprozil Tablets In Healthy Adults Volunteers Under Fed Conditions. |
Enrollment: | 35 |
Study Start Date: | March 2004 |
Study Completion Date: | April 2004 |
Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Cefprozil 500 mg Tablets (Sandoz, GmbH)
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Drug: Cefprozil 500 mg Tablets (Sandoz, GmbH) |
2: Active Comparator
Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb, USA)
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Drug: Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb, USA) |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Sandoz Inc. ( Eric Mittleberg, Ph.D, VP of Product Development ) |
Study ID Numbers: | AA17501 |
Study First Received: | April 14, 2009 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00881855 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antibiotics |
Anti-Infective Agents Cefprozil Anti-Bacterial Agents Malnutrition Healthy |
Anti-Infective Agents Anti-Bacterial Agents Cefprozil Therapeutic Uses Pharmacologic Actions |