Finasteride 5 mg Tablets Under Fasting Conditions

A Relative Bioavailability Study of Finasteride 5 mg Tablets Under Fasting Conditions

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Finasteride 5 mg tablets; Drug: PROSCAR®

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77042
      • Novum Pharmaceutical Research Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Finasteride; Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period	Drug: Finasteride 5 mg tablets; 1 x 5 mg, single dose fasting
Active Comparator: Proscar®; Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period	Drug: PROSCAR®; 1 x 5 mg, single dose fasting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax - Maximum Observed Concentration	Bioequivalence based on Cmax	Blood samples collected over 36 hour period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)	Bioequivalence based on AUC0-t	Blood samples collected over 36 hour period
AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	Bioequivalence based on AUCinf	Blood samples collected over 36 hour period

Collaborators and Investigators

• Sponsor: Teva Pharmaceuticals USA

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Primary Completion (Actual): June 1, 2002
• Study Completion (Actual): June 1, 2002

Study Registration Dates

• First Submitted: February 3, 2009
• First Submitted That Met QC Criteria: February 3, 2009
• First Posted (Estimate): February 4, 2009

Study Record Updates

• Last Update Posted (Estimate): September 11, 2009
• Last Update Submitted That Met QC Criteria: September 1, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy Subjects
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Urological Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; 5-alpha Reductase Inhibitors; Finasteride
• Other Study ID Numbers: B026535