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Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex 50 mg Tablet in Healthy Subjects Under Fasting Conditions

NCT01039233 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2009-12-24

No results posted yet for this study

Summary

The objective of this study is to compare the rate and extent of absorption of bicalutamide 50 mg tablet (test) versus Casodex (reference), administered as 1 x 50 mg tablet under fasting conditions

Conditions

  • Bioequivalency

Interventions

DRUG

Bicalutamide 50 mg Tablet vs Casodex® 50 mg Tablet

Sponsors & Collaborators

  • Watson Laboratories, Inc.

    collaborator INDUSTRY

  • Kremers Urban Development Company

    lead INDUSTRY

Principal Investigators

  • Richard Larouche, M.D. · SFBC Anapharm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
73 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2005-06-30
Completion
2005-07-31

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 NCT01039233 on ClinicalTrials.gov