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Casodex

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

Casodex · 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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Frequently asked questions about Casodex

What is Casodex?

Casodex is a small molecule drug being developed by Teva Pharmaceutical Industries Limited (TEVA). It is currently in Phase 1 clinical development for use in healthy subjects. The drug is being studied in two completed trials with a total enrollment of 120 participants.

What is Casodex used for?

Casodex is being studied for use in healthy subjects. The clinical trials are designed to evaluate the drug in healthy male volunteers under fed and fasting conditions. The drug is in Phase 1 development, and its use is limited to research in healthy individuals at this stage.

Who makes Casodex?

Casodex is being developed by Teva Pharmaceutical Industries Limited, a company listed on the stock exchange under the ticker TEVA. The drug is currently in Phase 1 clinical development, with two completed trials involving healthy subjects.

What phase is Casodex in?

Casodex is in Phase 1 clinical development. It is an investigational drug being studied in healthy subjects. Two Phase 1 trials have been completed, both involving healthy male volunteers, with a combined enrollment of 120 participants.

What clinical trials is Casodex in?

Casodex has been studied in two completed Phase 1 clinical trials: NCT00972855, which evaluated the drug in healthy subjects under fed conditions, and NCT00973050, which evaluated it under fasting conditions. Both trials were conducted in Canada with 60 male participants each.

Is Casodex the same as Bicalutamide?

Casodex is the brand name for bicalutamide, as indicated by the clinical trial titles that reference Bicalutamide 1 x 50 mg Tablet. The drug is being studied in healthy subjects and is currently in Phase 1 development by Teva Pharmaceutical Industries Limited.