Cefprozil 500 mg Tablets Under Fasting Conditions
Condition: Healthy
Intervention: Cefzil® 500 mg tablets; Cefprozil 500 mg Tablets
Intervention description: 1 x 500 mg, single-dose fasting; 1 x 500 mg, single-dose fasting
Intervention MeSH terms: Cefprozil
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      The objective of this study is to compare the relative bioavailability of cefprozil 500 mg
      tablets (Teva Pharmaceuticals USA) with that of Cefzil® 500 mg tablets (Bristol-Myers Squibb)
      in healthy, non-smoking adults under fasting conditions.
    

Eligibility 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.