Bioequivalence Study of Dr. Reddy’s Laboratories Limited, Finasteride Tablets 1 mg Under Fasting Condition

Overview

The objective of this study was to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Merck & Co. (Propecia®) 1 mg finasteride tablets under fasting conditions following administration of a 3 mg dose.

Full Title of Study: “Comparative,Randomized,Single-dose,2-way Crossover Bioavailability Study of Dr.Reddy’s Laboratories Limited Finasteride Tablets 1 mg and Merck & Co., Propecia Under Fasting Condition.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2002

Detailed Description

Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 24 healthy adult male volunteers and 2 alternates. A total of 24 subjects completed the clinical phase of the study. In each period, subjects were housed from the evening before dosing until after the 36-hour blood draw. Single oral 3 mg doses were separated by a washout period of 7 days.

Interventions

  • Drug: Finasteride
    • Finasteride tablets 1 mg

Arms, Groups and Cohorts

  • Experimental: Finasteride
    • Finasteride tablets 1 mg of Dr. Reddy’s
  • Active Comparator: Propecia
    • Propecia 1 mgTablets of Merck & Co.,

Clinical Trial Outcome Measures

Primary Measures

  • Bioequivalence based on Cmax and AUC parameters
    • Time Frame: 3 months

Participating in This Clinical Trial

Inclusion Criteria

Exclusion Criteria:

History or presence of significant: • cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease. In addition, history or presence of:

  • alcoholism or drug abuse within the past year; – hypersensitivity or idiosyncratic reaction to finasteride or any other 5-a reductase inhibitor. Subjects who have been on an abnormal diet (for whatever reason) during the 28 days preceding the study. Subjects who, through completion of the study, would have donated in excess of: – 500 mL of blood in 14 days, or – 500 – 750 mL of blood in 14 days (unless approved by the Principal Investigator), – 1000 mL of blood in 90 days, – 1250 mL of blood in 120 days, – 1500 mL of blood in 180 days, – 2000 mL of blood in 270 days, – 2500 mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days prior to the first dosing.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 45 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. Manager-Research and Development, Dr. Reddy’s Laboratories Limited
  • Overall Official(s)
    • Gaetano Morelli, MD, Principal Investigator, MDS Pharma Services

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