Interaction Clinical Trial
Official title:
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
Verified date | May 2013 |
Source | Inje University |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Korea: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | February 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Healthy male subject whose CYP2C19 genotype was determined Exclusion Criteria: - Subject who has abnormal laboratory test results |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Inje University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
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