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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01482117
Enrollment
28
Registered
2011-11-30
Start date
2011-11-30
Completion date
2012-02-29
Last updated
2013-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interaction

Keywords

CYP2C19, CYP3A5, Clopidogrel, Cilostazol, Healthy

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.

Interventions

DRUGClopidogrel

single oral administration of 300mg of clopidogrel

DRUGCilostazol

single oral administration of 100mg cilostazol

DRUGClopidogrel/Cilostazol

single oral administration of 300mg clopidogrel and 100mg cilostazol

Sponsors

Inje University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy male subject whose CYP2C19 genotype was determined

Exclusion criteria

* Subject who has abnormal laboratory test results

Design outcomes

Primary

MeasureTime frameDescription
Maximum concentration(Cmax), Area under the concentration(AUC), Inhibition of platelet aggregation(IPA)up to 24 hours9 or 11 point blood sampling according to the interventions

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026