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The Effect of Genetic Polymorphism on Interactions of Clopidogrel and Cilostazol in Healthy Volunteers

Not Applicable
Completed
Conditions
Interaction
Interventions
Drug: Clopidogrel/Cilostazol
Registration Number
NCT01482117
Lead Sponsor
Inje University
Brief Summary

The aim of this study is to investigate the effects of genetic polymorphisms on pharmacokinetic and pharmacodynamic interactions of clopidogrel and cilostazol in Korean healthy adult volunteers.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
28
Inclusion Criteria
  • Healthy male subject whose CYP2C19 genotype was determined
Exclusion Criteria
  • Subject who has abnormal laboratory test results

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
ClopidogrelClopidogrel/Cilostazolsingle oral administration of 300mg of clopidogrel
CilostaroleClopidogrelsingle oral administration of 100mg of cilostazole
CilostaroleCilostazolsingle oral administration of 100mg of cilostazole
CilostaroleClopidogrel/Cilostazolsingle oral administration of 100mg of cilostazole
Clopidogrel/CilostazolClopidogrelsingle oral administration of 300mg clopidogrel and 100mg cilostazol
Clopidogrel/CilostazolClopidogrel/Cilostazolsingle oral administration of 300mg clopidogrel and 100mg cilostazol
ClopidogrelClopidogrelsingle oral administration of 300mg of clopidogrel
ClopidogrelCilostazolsingle oral administration of 300mg of clopidogrel
Clopidogrel/CilostazolCilostazolsingle oral administration of 300mg clopidogrel and 100mg cilostazol
Primary Outcome Measures
NameTimeMethod
Maximum concentration(Cmax), Area under the concentration(AUC), Inhibition of platelet aggregation(IPA)up to 24 hours

9 or 11 point blood sampling according to the interventions

Secondary Outcome Measures
NameTimeMethod
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