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

December 20, 2010
December 21, 2010
December 21, 2010
November 2006
November 2006   (Final data collection date for primary outcome measure)
Bioequivalence based on Cmax and AUC parameters [ Time Frame: 2 months ]
Same as current
No Changes Posted
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Bioequivalence Study of Finasteride 5 mg Tablet Formulations Under Fasting Conditions
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.
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.
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.
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: Finasteride
Finasteride Tablets 5 mg
Other Name: Proscar
  • Experimental: Finasteride tablets 5 mg
    Finasteride tablets 5 mg of Dr.Reddy's Laboratories Limited
    Intervention: Drug: Finasteride
  • Active Comparator: Proscar 5 mg Tablets
    Proscar 5 mg Tablets of Merck & Co. Inc
    Intervention: Drug: Finasteride
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 2006
November 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
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Sr. Director- Research & Development, Dr. Reddy's Laboratories Limited
Dr. Reddy's Laboratories Limited
Not Provided
Principal Investigator: Darin B. Brimhall Novum Pharmaceutical Research Services
Dr. Reddy's Laboratories Limited
December 2006

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