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Bioequivalence Study of Finasteride 5 mg Tablet Formulations Under Fasting Conditions

NCT ID: NCT01264289

Last Updated: 2010-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2006-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Keywords

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Bioequivalence Finasteride crossover

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Finasteride tablets 5 mg

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

Group Type EXPERIMENTAL

Finasteride

Intervention Type DRUG

Finasteride Tablets 5 mg

Proscar 5 mg Tablets

Proscar 5 mg Tablets of Merck \& Co. Inc

Group Type ACTIVE_COMPARATOR

Finasteride

Intervention Type DRUG

Finasteride Tablets 5 mg

Interventions

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Finasteride

Finasteride Tablets 5 mg

Intervention Type DRUG

Other Intervention Names

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Proscar

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Dr. Reddy's Laboratories Limited

Principal Investigators

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Darin B. Brimhall

Role: PRINCIPAL_INVESTIGATOR

Novum Pharmaceutical Research Services

Locations

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Novum Pharmaceutical Research Services

Las Vegas, Nevada, United States

Site Status

Countries

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United States

Other Identifiers

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10640609

Identifier Type: -

Identifier Source: org_study_id