Fed Study of Finasteride Tablets 5 mg and Proscar® Tablets 5 mg

Overview

The objective of this study was to investigate the bioequivalence of Mylan's finasteride 5 mg tablets and Merck's Proscar® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administration under fed conditions.

Full Title of Study: “Single-Dose Food In Vivo Bioequivalence Study of Finasteride Tablets (5 mg; Mylan) to Proscar® Tablets (5 mg; Merck) in Healthy Male Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2004

Interventions

  • Drug: Finasteride Tablets 5 mg
    • 5mg, single dose fed
  • Drug: Proscar® Tablets 5 mg
    • 5mg, single dose fed

Arms, Groups and Cohorts

  • Experimental: 1
    • Finasteride Tablets 5 mg
  • Active Comparator: 2
    • Proscar® Tablets 5 mg

Clinical Trial Outcome Measures

Primary Measures

  • Bioequivalence
    • Time Frame: within 30 days

Participating in This Clinical Trial

Inclusion Criteria

1. Age: 18 years and older 2. Sex: Male During the course of the study, from study screen until study exit, male volunteers must use a spermicide-containing barrier method of contraception to prevent the pregnancy of their sexual partner. This advice should be documented in the informed consent form. 3. Weight: At least 60 kg (132 lbs) and all subjects within 15% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS). 4. All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, Hepatitis B, Hepatitis C and HIV tests, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication. Exclusion Criteria:

1. Institutionalized subjects will not be used. 2. Social Habits: 1. Use of any tobacco products within one year prior to dosing. 2. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication. 3. Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication. 4. Any recent, significant change in dietary or exercise habits. 3. Medications: 1. Use of any medication within the last 14 days prior to the initial dose of study medication, including over-the-counter medications. 2. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication. 4. Diseases: 1. History of any significant chronic disease and/or hepatitis. 2. History of drug and/or alcohol abuse. 3. Acute illness at the time of either the pre-study medical evaluation or dosing. 4. A positive HIV, Hepatitis B, or Hepatitis C test result. 5. Abnormal and clinically significant laboratory test results: 1. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS). 2. Abnormal and clinically relevant ECG tracing. 6. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication. 7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication. 8. Allergy or hypersensitivity to finasteride or other related products. 9. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption. 10. Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mylan Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Will Sullivan, Global Head of Product Risk and Safety Management, Mylan Inc.
  • Overall Official(s)
    • Dorian Williams, M.D., Principal Investigator, Kendle International Inc.

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