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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: March 27, 2017
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
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

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 ]

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   (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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881426

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

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: March 27, 2017

Keywords provided by Sandoz:
Antibiotic

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

ClinicalTrials.gov processed this record on September 19, 2017