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

Randomized, 2-Way Crossover Bioequivalence Study Finasteride 5 mg Tablet and Proscar Administrated as 1 x 5 mg Tablet in Healthy Subjects Under Fasting Conditions.

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Finasteride 5 mg Tablet, single dose; Drug: Proscar® 5 mg Tablet, single dose

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

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sainte-Foy, Quebec, Canada, G 1 V 2K8
      • SFBC Anapharm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Finasteride 5 mg single dose tablet, single dose	Drug: Finasteride 5 mg Tablet, single dose; A: Experimental Subjects received Intas Pharmaceuticals Ltd, India formulated products under fasting conditions; Other Names: Finasteride
Active Comparator: B; Proscar® 5 mg Tablet, single dose	Drug: Proscar® 5 mg Tablet, single dose; B: Active comparator Subjects received Merck Sharp and Dohme, U.S.A formulated products under fasting conditions; Other Names: Finasteride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate and Extend of Absorption	24 hours

Collaborators and Investigators

• Sponsor: Actavis Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Primary Completion (Actual): November 1, 2004
• Study Completion (Actual): November 1, 2004

Study Registration Dates

• First Submitted: March 26, 2009
• First Submitted That Met QC Criteria: March 26, 2009
• First Posted (Estimate): March 27, 2009

Study Record Updates

• Last Update Posted (Estimate): August 16, 2010
• Last Update Submitted That Met QC Criteria: August 13, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy subjects; finasteride
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Urological Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; 5-alpha Reductase Inhibitors; Finasteride
• Other Study ID Numbers: 40397