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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

Page last updated: August 20, 2015

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