Cefprozil 500 mg Tablets Under Fed Conditions

A Relative Bioavailability Study of Cefprozil 500 mg Tablets Under Non-Fasting Conditions

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: cefprozil; Drug: Cefzil®

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Charles, Missouri, United States, 63301
      • Gateway Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: cefprozil; 500 mg Tablet
Active Comparator: 2	Drug: Cefzil®; 500 mg Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)	Bioequivalence based on AUC0-t.	Blood samples collected over a 12 hour period.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)	Bioequivalence based on AUC0-inf.	Blood samples collected over a 12 hour period.
Cmax (Maximum Observed Concentration)	Bioequivalence based on Cmax.	Blood samples collected over a 12 hour period.

Collaborators and Investigators

• Sponsor: Teva Pharmaceuticals USA
• Investigators: Principal Investigator: Irwin Plisco, MD, Gateway Medical Research

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (Actual): September 1, 2003
• Study Completion (Actual): September 1, 2003

Study Registration Dates

• First Submitted: February 6, 2009
• First Submitted That Met QC Criteria: February 6, 2009
• First Posted (Estimate): February 10, 2009

Study Record Updates

• Last Update Posted (Estimate): August 20, 2009
• Last Update Submitted That Met QC Criteria: August 14, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy Subjects
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Cefprozil
• Other Study ID Numbers: B036557