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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01133444
Recruitment Status : Completed
First Posted : May 28, 2010
Last Update Posted : July 12, 2010
Information provided by:
Dr. Reddy's Laboratories Limited

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Finasteride Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : April 2002
Primary Completion Date : April 2002
Study Completion Date : May 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Finasteride
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Finasteride
Finasteride tablets 1 mg of Dr. Reddy's
Drug: Finasteride
Finasteride tablets 1 mg
Other Name: Propecia
Active Comparator: Propecia
Propecia 1 mgTablets of Merck & Co.,
Drug: Finasteride
Finasteride tablets 1 mg
Other Name: Propecia

Primary Outcome Measures :
  1. Bioequivalence based on Cmax and AUC parameters [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01133444

MDS Pharma Services
Cohen street, saint-laurent, montreal (quebec), Canada, H4R 2N6
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Principal Investigator: Gaetano Morelli, MD MDS Pharma Services

Responsible Party: Sr. Manager-Research and Development, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01133444     History of Changes
Other Study ID Numbers: 012742
First Posted: May 28, 2010    Key Record Dates
Last Update Posted: July 12, 2010
Last Verified: May 2010

Keywords provided by Dr. Reddy's Laboratories Limited:

Additional relevant MeSH terms:
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Urological Agents