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

NCT00871247 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2010-08-16

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Finasteride 5 mg Tablet, single dose

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

DRUG

Proscar® 5 mg Tablet, single dose

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

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • Benoit Girard, M.D. · SFBC Anapharm

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2004-11-30
Completion
2004-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00871247 on ClinicalTrials.gov