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Pletal

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

Pletal · 1 trial · 1 indication

Phase 1 1
NCT00881231To Demonstrate the Relative Bioavailability of Cilostazol 50 mg Tablets Under Fasting ConditionsPain
COMPLETED26 Analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability of Cilostazol 50 mg Tablets Under Fasting Conditions
Pain
NCT0088123126
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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 to 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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