Pravastatin 80 mg Tablets Dosed in Healthy Subjects Under Non-Fasting Conditions
Condition: Healthy
Intervention: Pravastatin; Pravastatin
Intervention description: 80 mg Tablet; 80 mg Tablets
Intervention MeSH terms: Pravastatin
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      This study compared the relative bioavailability (rate and extent of absorption) of
      Pravastatin Sodium Tablets 80 mg by Teva Pharmaceutical Industries, Ltd. with that of
      Pravachol® Tablets 80 mg by Bristol-Myers Squibb Company following a single oral dose (1 x 80
      mg tablet)in healthy adult male subjects administered under non-fasting conditions.
    

Eligibility criteria:

        Inclusion Criteria

          -  Screening Demographics: All subjects selected for this study will be healthy men 18
             years of age or older at the time of dosing.

          -  The subject's body mass index (BMI) should be less than or equal to 30.

          -  Screening Procedures: Each subject will complete the screening process within 28 days
             prior to period I dosing.

          -  Consent documents for both the screening evaluation and HIV antibody determination
             will be reviewed, discussed and signed by each potential participant before full
             implementation of screening procedures.

          -  Screening will include general observations, physical examination, demographics,
             medical and medication history, an electrocardiogram, sitting blood pressure and heart
             rate, respiratory rate and temperature.

          -  The physical examination will include, but may not be limited to, an evaluation of the
             cardiovascular, gastrointestinal, respiratory and central nervous systems.

          -  The screening clinical laboratory procedures will include:

               -  HEMATOLOGY: hematocrit, hemoglobin, WBC count with differential, RBC count,
                  platelet count

               -  CLINICAL CHEMISTRY: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin,
                  total bilirubin, total protein, and alkaline phosphatase

               -  HIV antibody, hepatitis GB surface antigen, hepatitis C antibody screens

               -  URINALYSIS: by dipstick; full microscopic examination if dipstick positive

               -  URINE DRUG SCREEN: ethyl alcohol, amphetamines, barbiturates, benzodiazepines,
                  cannabinoids, cocaine metabolites, opiates and phencyclidine

        Exclusion Criteria

          -  Subjects with a recent history of drug or alcohol addiction or abuse.

          -  Subjects with the presence of a clinically significant disorder involving the
             cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic,
             endocrine, or neurologic system(s) or psychiatric disease (as determined by the
             clinical investigators).

          -  Subjects whose clinical laboratory test values are outside the accepted reference
             range and when confirmed on re-examination are deemed to be clinically significant.

          -  Subjects demonstrating a reactive screen for hepatitis B surface antigen, hepatitis C
             antibody or HIV antibody.

          -  Subjects demonstrating a positive drug abuse screen when screened for this study.

          -  Subjects with a history of allergic response(s) to pravastatin or related drugs.

          -  Subjects with a history of clinically significant allergies including drug allergies.

          -  Subjects with a clinically significant illness during the 4 weeks prior to Period I
             dosing (as determined by the clinical investigators).

          -  Subjects who currently or report using tobacco products within 90 days of Period I
             dose administration.

          -  Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in
             the 28 days prior to Period I dosing.

          -  Subjects who report donating greater than 150 mL of blood within 28 days prior to
             Period I dosing. All subjects will be advised not to donate blood for four weeks after
             completing the study.

          -  Subjects who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period
             I dosing. All subjects will be advised not to donate plasma for four weeks after
             completing the study.

          -  Subjects who report receiving any investigational drug within 28 days prior to Period
             I dosing.

          -  Subjects who report taking any systemic prescription medication in the 14 days prior
             to Period I dosing.

          -  Subjects who report an intolerance of direct venipuncture.

          -  Subjects who report consuming an abnormal diet during the 28 days prior to Period I
             dosing.