Bioequivalence Study of Finasteride 5 mg Tablet Formulations Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01264289
First received: December 20, 2010
Last updated: NA
Last verified: December 2006
History: No changes posted
  Purpose

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 Intervention Phase
Healthy
Drug: Finasteride
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioequivalence based on Cmax and AUC parameters [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: November 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01264289

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

No publications provided

Responsible Party: Sr. Director- Research & Development, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01264289     History of Changes
Other Study ID Numbers: 10640609
Study First Received: December 20, 2010
Last Updated: December 20, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence
Finasteride
crossover

Additional relevant MeSH terms:
Finasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014