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Cefprozil for Oral Suspension 250 mg/5 mL, Non-Fasting
This study has been completed.
First Received: January 30, 2009   No Changes Posted
Sponsored by: Teva Pharmaceuticals USA
Information provided by: Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT00835354
  Purpose

The objective of this study is to compare the relative bioavailability of cefprozil for oral suspension 250 mg/5 mL (TEVA Pharmaceuticals USA) with that of CEFZIL® for Oral Suspension 250 mg/5 mL (Bristol-Myers Squibb) in healthy, non-smoking adults under non-fasting conditions.


Condition Intervention Phase
Healthy
Drug: Cefprozil for oral suspension 250 mg/5 mL
Drug: CEFZIL® for Oral Suspension 250 mg/5mL
Phase I

Drug Information available for: Cefprozil
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title: A Relative Bioavailability Study of Cefprozil for Oral Suspension 250 mg/5 mL Under Non-Fasting Conditions

Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Bioequivalence based on Cmax and AUC [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: May 2004
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Cefprozil for oral suspension 250 mg/5 mL
1 x 250 mg/5 mL, single-dose fasting
2: Active Comparator Drug: CEFZIL® for Oral Suspension 250 mg/5mL
1 x 250 mg/5 mL, single-dose fasting

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All subjects selected for this study will be non-smokers at least 18 years of age. Subjects will have a BMI (body mass index) of 30 or less.
  • Each subject shall be given a general physical examination within 28 days of initiation of the study. Such examination includes, but is not limited to, blood pressure, general observations, and history.
  • Each female subject will be given a serum pregnancy test as part of the pre-study screening process.
  • Adequate blood and urine samples should be obtained within 28 days before beginning of the first period and at the end of the trial for clinical laboratory measurements.
  • Clinical laboratory measurements will include the following:

    1. Hematology: hemoglobin, hematocrit, red blood cell count, platelets, and white blood cell count (with differential).
    2. Clinical Chemistry: creatinine, BUN, glucose, SGOT/AST, SGPT/ALT, bilirubin, and alkaline phosphatase.
    3. Urine Analysis: pH, specific gravity, protein, glucose, ketones, bilirubin, occult blood, and cells.
    4. HIV Screen: pre-study only.
    5. Hepatitis-B, C Screen: pre-study only.
    6. Drugs of Abuse Screen: pre-study and at each check-in

Exclusion Criteria:

  • Subjects with a significant recent history of chronic alcohol consumption (past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma (past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study.
  • Subjects whose clinical laboratory test values are outside the reference range may be retested at the discretion of the clinical investigator. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
  • Subjects who have a history of allergic responses to the class of drug being tested will be excluded from the study.
  • Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.
  • All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each dosing period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
  • Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.
  • Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
  • Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Female subjects who have used hormonal oral contraceptives within 14 days of dosing or implanted or injected hormonal contraceptives within 180 days of dosing will not be allowed to participate.
  • All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study.
  • Subjects who do not tolerate venipuncture will not be allowed to participate.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00835354

Locations
United States, Missouri
Gateway Medical Research, Inc.
St. Charles, Missouri, United States, 63301
United States, Texas
Bioassay Laboratory, Inc.
Houston, Texas, United States, 77099
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Steven Herrmann, M.D. Cetero Research
  More Information

No publications provided

Study ID Numbers: B036559
Study First Received: January 30, 2009
Last Updated: January 30, 2009
ClinicalTrials.gov Identifier: NCT00835354     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Study placed in the following topic categories:
Anti-Bacterial Agents
Cefprozil
Healthy

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

ClinicalTrials.gov processed this record on May 07, 2009