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To Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose Fasting Conditions.

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ClinicalTrials.gov Identifier: NCT00881153
Recruitment Status : Completed
First Posted : April 15, 2009
Last Update Posted : March 29, 2017
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose Fasting Conditions.

Condition or disease Intervention/treatment Phase
Healthy Drug: Cefprozil 250 mg/5 ml Oral Suspension (Sandoz GmbH) Drug: Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb) Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 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 Company (Cefzil) 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose In Healthy Adults Volunteers Under Fasting Conditions.
Study Start Date : May 2004
Primary Completion Date : June 2004
Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Cefprozil 250 mg/5 ml Oral Suspension (Sandoz GmbH)
Drug: Cefprozil 250 mg/5 ml Oral Suspension (Sandoz GmbH)
Active Comparator: 2
Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb)
Drug: Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb)


Outcome Measures

Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 15 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 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

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): NCT00881153


Sponsors and Collaborators
Sandoz
Investigators
Principal Investigator: Magdy L. Shenouda, M.D. MDS Pharma Services
More Information

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00881153     History of Changes
Other Study ID Numbers: AA17502
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