Overview

Cefprozil for Oral Suspension 250 mg/5 mL, Non-fasting

Status:
Completed
Trial end date:
2004-05-01
Target enrollment:
0
Participant gender:
All
Summary
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 CEFZILĀ® for Oral Suspension 250 mg/5 mL (Bristol-Myers Squibb) in healthy, non-smoking adults under non-fasting conditions.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Teva Pharmaceuticals USA
Treatments:
Cefprozil
Cephalosporins
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.