To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00881426
First received: April 14, 2009
Last updated: April 15, 2009
Last verified: April 2009
  Purpose

To demonstrate the relative bioavailability of Cefzil 500 mg Cefprozil tablets under fasting conditions.


Condition Intervention Phase
Healthy
Drug: Cefprozil 500 mg Tablets (Sandoz GmbH)
Drug: Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 16 days ] [ Designated as safety issue: No ]

Enrollment: 26
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
Experimental: 1
Cefprozil 500 mg Tablets (Sandoz GmbH)
Drug: Cefprozil 500 mg Tablets (Sandoz GmbH)
Active Comparator: 2
Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb)
Drug: Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb)

  Eligibility

Ages Eligible for Study:   20 Years to 54 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00881426

Sponsors and Collaborators
Sandoz Inc.
Investigators
Principal Investigator: Gaetano Morelli, M.D. MDS Pharma Services
  More Information

No publications provided

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00881426     History of Changes
Other Study ID Numbers: AA17499
Study First Received: April 14, 2009
Last Updated: April 15, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Sandoz:
Antibiotic

Additional relevant MeSH terms:
Cefprozil
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014