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

NCT01044706 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-03-02

Study results available
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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 fed conditions.

Conditions

  • Healthy

Interventions

DRUG

Bicalutamide

50 mg Oral Tablet

Sponsors & Collaborators

  • Watson Pharmaceuticals

    collaborator INDUSTRY

  • Kremers Urban Development Company

    lead INDUSTRY

Principal Investigators

  • Benoit Girard, M.D. · SFBC Anapharm

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2005-07-31
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 NCT01044706 on ClinicalTrials.gov