A Relative Bioavailability Study of Finasteride 5 mg Tablets Under Fasting Conditions

NCT ID: NCT00870480

Last Updated: 2010-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2004-11-30

Brief Summary

The purpose of this study to compare the rate and extent of absorption of Actavis Group hf, Iceland, finasteride and Merck & Co. Inc., U.S.A. (Proscar), finasteride, administered as a 1 x 5 mg tablet, under fasting conditions.

Detailed Description

Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.

Official Title: Randomized, 2-Way Crossover, Bioequivalence Study of Finasteride 5 mg Tablet and Proscar Administered as 1 x 5 mg Tablet in Healthy Subjects Under Fasting Conditions

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Rate and Extend of Absorption

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

A

Finasteride 5 mg single dose tablet, single dose

Group Type: EXPERIMENTAL

Finasteride 5 mg Tablet, single dose

Intervention Type: DRUG

A: Experimental Subjects received Intas Pharmaceuticals Ltd, India formulated products under fasting conditions

B

Proscar® 5 mg Tablet, single dose

Group Type: ACTIVE_COMPARATOR

Proscar® 5 mg Tablet, single dose

Intervention Type: DRUG

B: Active comparator Subjects received Merck Sharp and Dohme, U.S.A formulated products under fasting conditions

Interventions

Finasteride 5 mg Tablet, single dose

A: Experimental Subjects received Intas Pharmaceuticals Ltd, India formulated products under fasting conditions

Intervention Type: DRUG

Proscar® 5 mg Tablet, single dose

B: Active comparator Subjects received Merck Sharp and Dohme, U.S.A formulated products under fasting conditions

Intervention Type: DRUG

Other Intervention Names

Finasteride; Finasteride

Eligibility Criteria

Inclusion Criteria

• Male, smoker or non-smoker, 18 years of age and older.
• Capable of consent.
• BMI ~19.0 and <30.0 kg/m2 Sexual abstinence for the duration of the study is recommended given the potential harm to a fetus from migration of this drug to the semen. Sexually-active males must refrain from heterosexual intercourse without the use of a condom for a period of one week from the initial dosing.

Exclusion Criteria

• Clinically significant illnesses within 4 weeks prior to the administration of the study medication.
• Clinically significant surgery within 4 weeks prior to the administration of the study medication.
• Any clinically significant abnormality found during medical screening.
• Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
• Abnormal laboratory tests judged clinically significant.
• Positive testing for hepatitis B, hepatitis C, or HN at screening.
• EeG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
• History of significant alcohol abuse or drug abuse within one year prior to the screening visit.
• Regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [I Unit:= 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
• Use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP] and crack) within 1 year prior to the screening visit or positive urine drug screen at screening.
• History of allergic reactions to heparin, finasteride, or other related drugs.
• Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
• Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication .
• Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.

.• Any clinically significant history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.

• Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (incl~ding natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
• Difficulty to swallow study medication.
• Smoking more than 25 cigarettes per day.
• Any food alIergy, intolerance, restriction or special diet that, in the opinion of the Medical Sub-Investigator, could contraindicate the subject's participation in this study.
• A depot injection or an implant of any drug within 3 months prior to administration of study medication.
• Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows:
• 50 mL to 300 mL of whole blood within 30 days,
• 301 mL to 500 mL of whole blood within 45 days, or
• more than 500 mL of whole blood within 56 days prior to drug administration.
• Consumption of food or beverages containing grapefruit (e.g. fresh, canned, or frozen) within 7 days prior to administration of the study medication.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Actavis Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Actavis Inc

Principal Investigators

Benoit Girard, M.D.

Role: PRINCIPAL_INVESTIGATOR

SFBC Anapharm

Locations

SFBC Anapharm

Sainte-Foy, Quebec, Canada

Countries

Canada

Other Identifiers

40397

Identifier Type: -

Identifier Source: org_study_id