Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

April 14, 2009
April 15, 2009
March 2004
April 2004   (final data collection date for primary outcome measure)
Bioequivalence based on AUC and Cmax [ Time Frame: 16 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00881426 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fasting Conditions
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: Cefprozil 500 mg Tablets (Sandoz GmbH)
  • Drug: Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb)
  • Experimental: 1
    Cefprozil 500 mg Tablets (Sandoz GmbH)
    Intervention: Drug: Cefprozil 500 mg Tablets (Sandoz GmbH)
  • Active Comparator: 2
    Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb)
    Intervention: Drug: Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
April 2004
April 2004   (final data collection date for primary outcome measure)

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.
Both
20 Years to 54 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00881426
AA17499
Not Provided
Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz Inc.
Not Provided
Principal Investigator: Gaetano Morelli, M.D. MDS Pharma Services
Sandoz
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP