Cefprozil 500 mg Tablets Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00840866
First received: February 6, 2009
Last updated: August 14, 2009
Last verified: August 2009
  Purpose

The objective of this study is to compare the relative bioavailability of cefprozil 500 mg tablets with that of Cefzil 500 mg tablets in healthy, non-smoking adults under non-fasting conditions.


Condition Intervention Phase
Healthy
Drug: cefprozil
Drug: Cefzil®
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Relative Bioavailability Study of Cefprozil 500 mg Tablets Under Non-Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax (Maximum Observed Concentration) [ Time Frame: Blood samples collected over a 12 hour period. ] [ Designated as safety issue: No ]
  • AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [ Time Frame: Blood samples collected over a 12 hour period. ] [ Designated as safety issue: No ]
  • AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) [ Time Frame: Blood samples collected over a 12 hour period. ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: September 2003
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: cefprozil
500 mg Tablet
Active Comparator: 2 Drug: Cefzil®
500 mg Tablet

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:

  • 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.
  • At the end of the study, the subjects will have an exit evaluation consisting of interim history, global evaluation, and clinical laboratory measurements.
  • 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.

    • HEMATOLOGY: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count
    • CLINICAL CHEMISTRY: creatinine, BUN, glucose, SGOT/AST, SGPT/ALT, bilirubin, and alkaline phosphatase
    • HIV antibody, hepatitis B surface antigen, hepatitis C antibody screens
    • URINE ANALYSIS: pH, specific gravity, protein, glucose, ketones, bilirubin, occult blood, and cells
    • Drugs of Abuse Screen

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 greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, subjects will not be eligible to participate in the study unless the clinical investigator deems the results 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 froom 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
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: NCT00840866

Locations
United States, Missouri
Gateway Medical Research
St. Charles, Missouri, United States, 63301
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Irwin Plisco, MD Gateway Medical Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00840866     History of Changes
Other Study ID Numbers: B036557
Study First Received: February 6, 2009
Results First Received: June 18, 2009
Last Updated: August 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

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

ClinicalTrials.gov processed this record on October 23, 2014