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
Overview
- Phase
- Not Applicable
- Intervention
- Clopidogrel
- Conditions
- Interaction
- Sponsor
- Inje University
- Enrollment
- 28
- Primary Endpoint
- Maximum concentration(Cmax), Area under the concentration(AUC), Inhibition of platelet aggregation(IPA)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Jae-Gook Shin
Department of Pharmacology and Pharmacogenomics Research Center
Inje University
Eligibility Criteria
Inclusion Criteria
- •Healthy male subject whose CYP2C19 genotype was determined
Exclusion Criteria
- •Subject who has abnormal laboratory test results
Arms & Interventions
Clopidogrel
single oral administration of 300mg of clopidogrel
Intervention: Clopidogrel
Clopidogrel
single oral administration of 300mg of clopidogrel
Intervention: Cilostazol
Clopidogrel
single oral administration of 300mg of clopidogrel
Intervention: Clopidogrel/Cilostazol
Cilostarole
single oral administration of 100mg of cilostazole
Intervention: Clopidogrel
Cilostarole
single oral administration of 100mg of cilostazole
Intervention: Cilostazol
Cilostarole
single oral administration of 100mg of cilostazole
Intervention: Clopidogrel/Cilostazol
Clopidogrel/Cilostazol
single oral administration of 300mg clopidogrel and 100mg cilostazol
Intervention: Clopidogrel
Clopidogrel/Cilostazol
single oral administration of 300mg clopidogrel and 100mg cilostazol
Intervention: Cilostazol
Clopidogrel/Cilostazol
single oral administration of 300mg clopidogrel and 100mg cilostazol
Intervention: Clopidogrel/Cilostazol
Outcomes
Primary Outcomes
Maximum concentration(Cmax), Area under the concentration(AUC), Inhibition of platelet aggregation(IPA)
Time Frame: up to 24 hours
9 or 11 point blood sampling according to the interventions