Fasting Study of Finasteride Tablets 5 mg and Proscar Tablets 5 mg

This study has been completed.
Sponsor:
Information provided by:
Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00648791
First received: March 30, 2008
Last updated: March 31, 2008
Last verified: March 2008

March 30, 2008
March 31, 2008
September 2004
October 2004   (final data collection date for primary outcome measure)
Bioequivalence [ Time Frame: within 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00648791 on ClinicalTrials.gov Archive Site
Not Provided
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Fasting Study of Finasteride Tablets 5 mg and Proscar Tablets 5 mg
Single-Dose Fasting In Vivo Bioequivalence Study of Finasteride Tablets (5 mg; Mylan) and Proscar Tablets (5 mg; Merck) in Healthy Male Volunteers

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Finasteride Tablets 5 mg
    5mg, single dose fasting
  • Drug: Proscar Tablets 5 mg
    5mg, single dose fasting
  • Experimental: 1
    Finasteride Tablets 5 mg
    Intervention: Drug: Finasteride Tablets 5 mg
  • Active Comparator: 2
    Proscar Tablets 5 mg
    Intervention: Drug: Proscar Tablets 5 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
October 2004
October 2004   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00648791
FINA-0460
Not Provided
Will Sullvan, Global Head of Product Risk and Safety Management, Mylan Inc.
Mylan Pharmaceuticals
Not Provided
Principal Investigator: Dorian Williams, M.D. Kendle International Inc.
Mylan Pharmaceuticals
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP