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Bioequivalence Study of Finasteride 5 mg Tablet Formulations Under Fasting Conditions

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. Identifier: NCT01264289
Recruitment Status : Completed
First Posted : December 21, 2010
Last Update Posted : December 21, 2010
Information provided by:
Dr. Reddy's Laboratories Limited

Brief Summary:
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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : November 2006
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Finasteride

Arm Intervention/treatment
Experimental: Finasteride tablets 5 mg
Finasteride tablets 5 mg of Dr.Reddy's Laboratories Limited
Drug: Finasteride
Finasteride Tablets 5 mg
Other Name: Proscar

Active Comparator: Proscar 5 mg Tablets
Proscar 5 mg Tablets of Merck & Co. Inc
Drug: Finasteride
Finasteride Tablets 5 mg
Other Name: Proscar

Primary Outcome Measures :
  1. Bioequivalence based on Cmax and AUC parameters [ Time Frame: 2 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT01264289

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United States, Nevada
Novum Pharmaceutical Research Services
Las Vegas,, Nevada, United States, 89121
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
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Principal Investigator: Darin B. Brimhall Novum Pharmaceutical Research Services

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Responsible Party: Sr. Director- Research & Development, Dr. Reddy's Laboratories Limited Identifier: NCT01264289     History of Changes
Other Study ID Numbers: 10640609
First Posted: December 21, 2010    Key Record Dates
Last Update Posted: December 21, 2010
Last Verified: December 2006

Keywords provided by Dr. Reddy's Laboratories Limited:

Additional relevant MeSH terms:
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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