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

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Open-label, Crossover Study to Evaluate the Effect of Genetic Polymorphism on Pharmacokinetic & Pharmacodynamic Interactions of Clopidogrel and Cilostazol in Korean Healthy Adult Volunteers

Conditions
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Interaction

Intervention / Treatment
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* Drug: Clopidogrel
* Drug: Cilostazol
* Drug: Clopidogrel/Cilostazol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subject whose CYP2C19 genotype was determined Exclusion Criteria: Subject who has abnormal laboratory test results

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clopidogrel<br>single oral administration of 300mg of clopidogrel | Drug: Clopidogrel<br>* single oral administration of 300mg of clopidogrel<br>* Other names: Plavix;Drug: Cilostazol<br>* single oral administration of 100mg cilostazol<br>* Other names: Pletaal;Drug: Clopidogrel/Cilostazol<br>* single oral administration of 300mg clopidogrel and 100mg cilostazol<br>* Other names: Plavix/Pletaal;|
| Active Comparator: Cilostarole<br>single oral administration of 100mg of cilostazole | Drug: Clopidogrel<br>* single oral administration of 300mg of clopidogrel<br>* Other names: Plavix;Drug: Cilostazol<br>* single oral administration of 100mg cilostazol<br>* Other names: Pletaal;Drug: Clopidogrel/Cilostazol<br>* single oral administration of 300mg clopidogrel and 100mg cilostazol<br>* Other names: Plavix/Pletaal;|
| Active Comparator: Clopidogrel/Cilostazol<br>single oral administration of 300mg clopidogrel and 100mg cilostazol | Drug: Clopidogrel<br>* single oral administration of 300mg of clopidogrel<br>* Other names: Plavix;Drug: Cilostazol<br>* single oral administration of 100mg cilostazol<br>* Other names: Pletaal;Drug: Clopidogrel/Cilostazol<br>* single oral administration of 300mg clopidogrel and 100mg cilostazol<br>* Other names: Plavix/Pletaal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration(Cmax), Area under the concentration(AUC), Inhibition of platelet aggregation(IPA) | 9 or 11 point blood sampling according to the interventions | up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CYP2C19, CYP3A5, Clopidogrel, Cilostazol, Healthy