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

May 31, 2013 updated by: Jae-Gook Shin, Inje University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male subject whose CYP2C19 genotype was determined

Exclusion Criteria:

  • Subject who has abnormal laboratory test results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Clopidogrel
single oral administration of 300mg of clopidogrel
Drug: Clopidogrel
single oral administration of 300mg of clopidogrel
Other Names:
  • Plavix
Drug: Cilostazol
single oral administration of 100mg cilostazol
Other Names:
  • Pletaal
Drug: Clopidogrel/Cilostazol
single oral administration of 300mg clopidogrel and 100mg cilostazol
Other Names:
  • Plavix/Pletaal
Active Comparator: Cilostarole
single oral administration of 100mg of cilostazole
Drug: Clopidogrel
single oral administration of 300mg of clopidogrel
Other Names:
  • Plavix
Drug: Cilostazol
single oral administration of 100mg cilostazol
Other Names:
  • Pletaal
Drug: Clopidogrel/Cilostazol
single oral administration of 300mg clopidogrel and 100mg cilostazol
Other Names:
  • Plavix/Pletaal
Active Comparator: Clopidogrel/Cilostazol
single oral administration of 300mg clopidogrel and 100mg cilostazol
Drug: Clopidogrel
single oral administration of 300mg of clopidogrel
Other Names:
  • Plavix
Drug: Cilostazol
single oral administration of 100mg cilostazol
Other Names:
  • Pletaal
Drug: Clopidogrel/Cilostazol
single oral administration of 300mg clopidogrel and 100mg cilostazol
Other Names:
  • Plavix/Pletaal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum concentration(Cmax), Area under the concentration(AUC), Inhibition of platelet aggregation(IPA)
Time Frame: up to 24 hours
9 or 11 point blood sampling according to the interventions
up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inje University

Investigators

  • Principal Investigator: Jae-Gook Shin, MD, PhD, Inje University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

November 26, 2011

First Submitted That Met QC Criteria

November 26, 2011

First Posted (Estimate)

November 30, 2011

Study Record Updates

Last Update Posted (Estimate)

June 3, 2013

Last Update Submitted That Met QC Criteria

May 31, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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