Bioequivalence Study of Finasteride 5 mg Tablet Formulations Under Fasting Conditions

Overview

The objective of this study was to evaluate the relative bioavailability of the test formulation of finasteride 5 mg tablets (Dr. Reddy's Laboratories Limited) with the reference formulation PROSCAR® 5 mg Tablet (Merck & Co., Inc.)under fasting conditions in healthy adult male subjects.

Full Title of Study: “A Randomized, Single-dose, Two-treatment, Two-way, Crossover Bioequivalence Study of Finasteride 5 mg Tablets (Dr. Reddy’s Laboratories Limited) With the Reference Formulation PROSCAR® 5 mg Tablet (Merck & Co., Inc.) Under Fasting Conditions in Healthy Adult Male Subjects.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2006

Detailed Description

This randomized, single-dose, two-treatment, two-way, crossover study was conducted to compare the relative bioavailability of two formulations of 5 mg finasteride tablets under fasted conditions. The study was conducted with 26 (25 completed) healthy adults. The subjects received the test product in one study period and the reference product in the other period; the order of administration was according to the dosing randomization schedule. There was a 7-day interval between treatments.

Interventions

  • Drug: Finasteride
    • Finasteride Tablets 5 mg

Arms, Groups and Cohorts

  • Experimental: Finasteride tablets 5 mg
    • Finasteride tablets 5 mg of Dr.Reddy’s Laboratories Limited
  • Active Comparator: Proscar 5 mg Tablets
    • Proscar 5 mg Tablets of Merck & Co. Inc

Clinical Trial Outcome Measures

Primary Measures

  • Bioequivalence based on Cmax and AUC parameters
    • Time Frame: 2 months

Participating in This Clinical Trial

Inclusion Criteria

1. Males, 18-65 years of age (inclusive). 2. A body mass index (BMI) of 18-30 kg/m2 inclusive as calculated according to Novum Standard Operating Procedures. 3. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening. 4. Signed and dated informed consent form, which meets all criteria of current FDA regulations. Exclusion Criteria:

1. Female. 2. History of allergy or sensitivity to finasteride, or similar drugs, or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study. 3. Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction. 4. Presence of gastrointestinal disease or history of malabsorption within the last year. 5. History of psychiatric disorders occurring within the last two years that required hospitalization or medication. 6. Presence of a medical condition requiring regular treatment with prescription drugs. 7. Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to initial dosing. 8. Receipt of any drug as part of a research study within 30 days prior to dosing. 9. Drug or alcohol addiction requiring treatment in the past 12 months. 10. Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma within 14 days prior to dosing. 11. Positive test results for HIV, Hepatitis B surface antigen, or Hepatitis C antibody. 12. Positive test results for drugs of abuse at screening.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Dr. Reddy’s Laboratories Limited
  • Provider of Information About this Clinical Study
    • Sr. Director- Research & Development, Dr. Reddy’s Laboratories Limited
  • Overall Official(s)
    • Darin B. Brimhall, Principal Investigator, Novum Pharmaceutical Research Services

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