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Bioequivalence Study of Two Finasteride 5 mg Tablet Formulations Under Non-Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01264302
First received: December 20, 2010
Last updated: NA
Last verified: December 2006
History: No changes posted

December 20, 2010
December 20, 2010
November 2006
November 2006   (final data collection date for primary outcome measure)
Bioequivalence based on Cmax and AUC parameters [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Bioequivalence Study of Two Finasteride 5 mg Tablet Formulations Under Non-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 Fed 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 fed 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 fed conditions. The study was conducted with 26 (24 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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
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.
Male
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01264302
10640610
No
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