Overview

Finasteride 5 mg Tablets Under Fasting Conditions

Status:
Completed
Trial end date:
2002-06-01
Target enrollment:
0
Participant gender:
Male
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 PROSCARĀ® 5 mg tablets (Merck) in healthy, adult, non-smoking, male subjects under fasting conditions.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Teva Pharmaceuticals USA
Treatments:
Finasteride
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.