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

Information source: Inje University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Interaction

Intervention: Clopidogrel (Drug); Cilostazol (Drug); Clopidogrel/Cilostazol (Drug)

Phase: N/A

Status: Completed

Sponsored by: Inje University

Official(s) and/or principal investigator(s):
Jae-Gook Shin, MD, PhD, Principal Investigator, Affiliation: Inje University

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.

Clinical Details

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

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

Primary outcome: Maximum concentration(Cmax), Area under the concentration(AUC), Inhibition of platelet aggregation(IPA)

Eligibility

Minimum age: 20 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Healthy male subject whose CYP2C19 genotype was determined

Exclusion Criteria:

- Subject who has abnormal laboratory test results

Locations and Contacts

Additional Information

Starting date: November 2011
Last updated: May 31, 2013

Page last updated: August 23, 2015

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