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

NCT ID: NCT01482117

Last Updated: 2013-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Interaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Clopidogrel

single oral administration of 300mg of clopidogrel

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

single oral administration of 300mg of clopidogrel

Cilostazol

Intervention Type DRUG

single oral administration of 100mg cilostazol

Clopidogrel/Cilostazol

Intervention Type DRUG

single oral administration of 300mg clopidogrel and 100mg cilostazol

Cilostarole

single oral administration of 100mg of cilostazole

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

single oral administration of 300mg of clopidogrel

Cilostazol

Intervention Type DRUG

single oral administration of 100mg cilostazol

Clopidogrel/Cilostazol

Intervention Type DRUG

single oral administration of 300mg clopidogrel and 100mg cilostazol

Clopidogrel/Cilostazol

single oral administration of 300mg clopidogrel and 100mg cilostazol

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

single oral administration of 300mg of clopidogrel

Cilostazol

Intervention Type DRUG

single oral administration of 100mg cilostazol

Clopidogrel/Cilostazol

Intervention Type DRUG

single oral administration of 300mg clopidogrel and 100mg cilostazol

Interventions

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Clopidogrel

single oral administration of 300mg of clopidogrel

Intervention Type DRUG

Cilostazol

single oral administration of 100mg cilostazol

Intervention Type DRUG

Clopidogrel/Cilostazol

single oral administration of 300mg clopidogrel and 100mg cilostazol

Intervention Type DRUG

Other Intervention Names

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Plavix Pletaal Plavix/Pletaal

Eligibility Criteria

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Inclusion Criteria

* Healthy male subject whose CYP2C19 genotype was determined

Exclusion Criteria

* Subject who has abnormal laboratory test results
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Inje University

OTHER

Sponsor Role lead

Responsible Party

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Jae-Gook Shin

Department of Pharmacology and Pharmacogenomics Research Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jae-Gook Shin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Inje University

Other Identifiers

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10-105

Identifier Type: -

Identifier Source: org_study_id

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