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Cilostazol

Phase 1

Pain | Small molecule | Pain |Novartis AG|Last Updated: Mar 28, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00881231To Demonstrate the Relative Bioavailability of Cilostazol 50 mg Tablets Under Fasting ConditionsPHASE1 COMPLETED 26Jan 1, 2004Feb 1, 2004Mar 28, 2017 -
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Study Endpoints
Primary Endpoints
Bioequivalence based on AUC and Cmax
21 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALCilostazol 50 mg Tablets (Eon Pharma, LLC, USA)
2ACTIVE_COMPARATORPletal (Cilostazol) 50 mg Tablets (Otsuka Pharma Co, Ltd., USA)
Interventions
NameTypeDescription
Cilostazol 50 mg Tablets (Eon Pharma, LLC, USA)DRUG -
Pletal (Cilostazol) 50 mg Tablets (Otsuka Pharma Co, Ltd., USA)DRUG -
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Eligibility Criteria
Age Range19 Years — 50 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.

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