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OpenTrials
Completed

NCT Number: NCT01482117

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

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Key information

Conditions

Interaction

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male subject whose CYP2C19 genotype was determined

Exclusion criteria

  • Subject who has abnormal laboratory test results

Treatment and study plan

clopidogrel

Drug

single oral administration of 300mg of clopidogrel

Other names: Plavix

Cilostazol

Drug

single oral administration of 100mg cilostazol

Other names: Pletaal

Clopidogrel/Cilostazol

Drug

single oral administration of 300mg clopidogrel and 100mg cilostazol

Other names: Plavix/Pletaal

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 30, 2011
Registry last updated
Jun 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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