To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fasting Conditions
Information source: Sandoz
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Cefprozil 500 mg Tablets (Sandoz GmbH) (Drug); Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Sandoz Inc. Official(s) and/or principal investigator(s): Gaetano Morelli, M.D., Principal Investigator, Affiliation: MDS Pharma Services
Summary
To demonstrate the relative bioavailability of Cefzil 500 mg Cefprozil tablets under fasting
conditions.
Clinical Details
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 Fasting Conditions
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bioequivalence based on AUC and Cmax
Eligibility
Minimum age: 20 Years.
Maximum age: 54 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- No clinically significant abnormal finding on physical exam, medical history, or
clinical laboratory results on screening.
Exclusion Criteria:
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
Locations and Contacts
Additional Information
Starting date: March 2004
Last updated: April 15, 2009
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