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Bicalutamide

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Sep 9, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

Bicalutamide · 2 trials · 1 indication

Phase 1 2
NCT00972855Study of Bicalutamide 1 x 50 mg Tablet in Healthy Subjects Under Fed ConditionsHealthy
COMPLETED60 Analytics
NCT00973050Study of Bicalutamide 1 x 50 mg Tablet in Healthy Subjects Under Fasting ConditionsHealthy
COMPLETED60 Analytics
PHASE1COMPLETED
Study of Bicalutamide 1 x 50 mg Tablet in Healthy Subjects Under Fed Conditions
Healthy
NCT0097285560
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PHASE1COMPLETED
Study of Bicalutamide 1 x 50 mg Tablet in Healthy Subjects Under Fasting Conditions
Healthy
NCT0097305060
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Study Endpoints

Primary Endpoints

Cmax - Maximum Observed Concentration
Blood samples collected over 72 hour period
AUC0-72 - Area under the concentration-time curve from time zero to 72 hours post dose
Blood samples collected over 72 hour period
AUC0-72: Area under the concentration-time curve from time zero to 72 hours post-dose.
Blood samples collected over 72 hour period
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
BicalutamideEXPERIMENTALBicalutamide 50 mg Tablet
Casodex®ACTIVE_COMPARATORCasodex® 50 mg Tablet
Bicalutamide (test)EXPERIMENTALBicalutamide Tablet, 50 mg
Casodex® (reference)ACTIVE_COMPARATORCasodex® Tablet, 50 mg

Interventions

NameTypeDescription
BicalutamideDRUG50 mg Tablet
Casodex®DRUG50 mg Tablet
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects will be males, non-smokers, 18 years of age and older. Exclusion Criteria: Subjects to whom any of the following applies will be excluded from the study: * Clinically significant illnesses within 4 weeks of the administration of study medication. * Clinically signi...

Countries:Canada
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