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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Finasteride

• Registration Number: NCT01264302
• Lead Sponsor: 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 fed conditions in healthy adult male subjects.

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 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.

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2006-12
• Study First Submitted: 2010-12-20
• Study First Submitted QC: 2010-12-20
• Last Update Submitted: 2010-12-20
• Study First Posted: 2010-12-21
• Last Update Posted: 2010-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Finasteride tablets 5 mg	Finasteride	Finasteride tablets 5 mg of Dr.Reddy's Laboratories Limited
Proscar 5 mg Tablets	Finasteride	Proscar 5 mg Tablets of Merck \& Co. Inc

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on Cmax and AUC parameters	2 months

Trial Locations

Locations (1)

Novum Pharmaceutical Research Services; 🇺🇸 Las Vegas,, Nevada, United States