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

NCT01264302 | Completed Phase 1

• 1 other identifier: 10640610
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioequivalence; Finasteride; crossover

Outcome Measures

Primary Outcomes (1)

• Bioequivalence based on Cmax and AUC parameters

  2 months

Study Arms (2)

Finasteride tablets 5 mg

EXPERIMENTAL

Finasteride tablets 5 mg of Dr.Reddy's Laboratories Limited

Drug: Finasteride

Proscar 5 mg Tablets

ACTIVE COMPARATOR

Proscar 5 mg Tablets of Merck \& Co. Inc

Drug: Finasteride

Interventions

Finasteride DRUG

Finasteride Tablets 5 mg

Also known as: Proscar

Finasteride tablets 5 mg; Proscar 5 mg Tablets

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males, 18-65 years of age (inclusive).
• A body mass index (BMI) of 18-30 kg/m2 inclusive as calculated according to Novum Standard Operating Procedures.
• Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
• Signed and dated informed consent form, which meets all criteria of current FDA regulations.

You may not qualify if:

• Female.
• 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.
• Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction.
• Presence of gastrointestinal disease or history of malabsorption within the last year.
• History of psychiatric disorders occurring within the last two years that required hospitalization or medication.
• Presence of a medical condition requiring regular treatment with prescription drugs.
• Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to initial dosing.
• Receipt of any drug as part of a research study within 30 days prior to dosing.
• Drug or alcohol addiction requiring treatment in the past 12 months.
• Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma within 14 days prior to dosing.
• Positive test results for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
• Positive test results for drugs of abuse at screening.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Novum Pharmaceutical Research Services

Las Vegas, Nevada, 89121, United States

Location

MeSH Terms

Interventions

Finasteride

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Study Officials

• Darin B. Brimhall

  Novum Pharmaceutical Research Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 21, 2010
• Study Start: November 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: December 21, 2010

Record last verified: 2006-12

Locations

US (1)