Overview

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

Status:
Completed
Trial end date:
2004-11-01
Target enrollment:
0
Participant gender:
Male
Summary
The purpose of this study is 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 fed conditions.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Actavis Inc.
Treatments:
Finasteride
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.