Finasteride 5 mg Tablets Under Fasting Conditions
Condition: Healthy
Intervention: Finasteride 5 mg tablets; PROSCAR®
Intervention description: 1 x 5 mg, single dose fasting; 1 x 5 mg, single dose fasting
Intervention MeSH terms: Finasteride
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: Male
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 finasteride 5 mg
      tablets (manufactured and distributed by TEVA Pharmaceuticals USA) with that of PROSCAR® 5 mg
      tablets (Merck) in healthy, adult, non-smoking, male subjects under fasting conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All subjects selected for this study will be male 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.

        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: hemoglobin, hematocrit, red blood cell count, platelet count, white blood
             cell count (with differential).

          -  Clinical Chemistry: creatinine, BUN, glucose, SGOT/AST, SGPT/ALT, bilirubin, and
             alkaline phosphatase.

          -  Urine Analysis: pH, specific gravity, protein, glucose, ketones, bilirubin, occult
             blood, and cells.

          -  HIV Screen: pre-study

          -  Hepatitis B, C Screen: pre-study

          -  Drugs of Abuse Screen: pre-study and at each check-in Subjects will be selected if all
             above are normal. Electrocardiograms of all participating subjects will be recorded
             before initiation of the study and filed with each subject's case report forms.

        Exclusion Criteria:

          -  Subjects with a history of chronic alcohol consumption (during past 2 years), drug
             addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease,
             tuberculosis, epilepsy, asthma (during 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 on retesting, the subject will not be significant.

          -  Subjects who have a history of allergic responses to the class of drug being tested
             should be excluded from the study.

          -  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 study period
             check-in. subjects found to have urin 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.

          -  Subjects who do not tolerate venipuncture will not be allowed to participate.

          -  Subjects who use tobacco in any form will not be eligible to participate in the study.
             Three months abstinence is require.

          -  Females will not be eligible to participate in the study.