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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01482117
Other study ID # 10-105
Secondary ID
Status Completed
Phase N/A
First received November 26, 2011
Last updated May 31, 2013
Start date November 2011
Est. completion date February 2012

Study information

Verified date May 2013
Source Inje University
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Drug:
Clopidogrel
single oral administration of 300mg of clopidogrel
Cilostazol
single oral administration of 100mg cilostazol
Clopidogrel/Cilostazol
single oral administration of 300mg clopidogrel and 100mg cilostazol

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Inje University

Outcome

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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