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

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ClinicalTrials.gov Identifier: NCT00881426
Recruitment Status : Completed
First Posted : April 15, 2009
Last Update Posted : March 29, 2017
Sponsor:
Information provided by:
Sandoz

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : March 2004
Actual Primary Completion Date : April 2004
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Cefprozil
U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 16 days ]


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Ages Eligible for Study:   20 Years to 54 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00881426


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

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00881426     History of Changes
Other Study ID Numbers: AA17499
First Posted: April 15, 2009    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: April 2009

Keywords provided by Sandoz:
Antibiotic

Additional relevant MeSH terms:
Cefprozil
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents