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

NCT00870480 | Completed Phase 1

• 1 other identifier: 40397
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioequivalence; finasteride; Healthy subjects

Outcome Measures

Primary Outcomes (1)

• Rate and Extend of Absorption

  24 hours

Study Arms (2)

A

EXPERIMENTAL

Finasteride 5 mg single dose tablet, single dose

Drug: Finasteride 5 mg Tablet, single dose

B

ACTIVE COMPARATOR

Proscar® 5 mg Tablet, single dose

Drug: Proscar® 5 mg Tablet, single dose

Interventions

Finasteride 5 mg Tablet, single dose DRUG

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

Also known as: Finasteride

A

Proscar® 5 mg Tablet, single dose DRUG

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

Also known as: Finasteride

B

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (1)

SFBC Anapharm

Sainte-Foy, Quebec, G 1 V 2K8, Canada

Location

MeSH Terms

Interventions

Finasteride; Tablets

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Benoit Girard, M.D.

  SFBC Anapharm

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 27, 2009
• Study Start: November 1, 2004
• Primary Completion: November 1, 2004
• Study Completion: November 1, 2004
• Last Updated: August 16, 2010

Record last verified: 2010-08

Locations

CA (1)