Finasteride 5 mg Tablets Under Fasting Conditions

NCT ID: NCT00835666

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30
• Study Completion Date: 2002-06-30

Brief 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.

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Finasteride

Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period

Group Type: EXPERIMENTAL

Finasteride 5 mg tablets

Intervention Type: DRUG

1 x 5 mg, single dose fasting

Proscar®

Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period

Group Type: ACTIVE_COMPARATOR

PROSCAR®

Intervention Type: DRUG

1 x 5 mg, single dose fasting

Interventions

Finasteride 5 mg tablets

1 x 5 mg, single dose fasting

Intervention Type: DRUG

PROSCAR®

1 x 5 mg, single dose fasting

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role: lead

Principal Investigators

So Ran Hong, M.D.

Role: PRINCIPAL_INVESTIGATOR

Novum Pharmaceutical Research Services

Locations

Novum Pharmaceutical Research Services

Houston, Texas, United States

Countries

United States

Other Identifiers

B026535

Identifier Type: -

Identifier Source: org_study_id