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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01482117
First Posted: November 30, 2011
Last Update Posted: June 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jae-Gook Shin, Inje University
  Purpose
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.

Condition Intervention
Interaction Drug: Clopidogrel Drug: Cilostazol Drug: Clopidogrel/Cilostazol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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

Resource links provided by NLM:


Further study details as provided by Jae-Gook Shin, Inje University:

Primary Outcome Measures:
  • 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


Enrollment: 28
Study Start Date: November 2011
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clopidogrel
single oral administration of 300mg of clopidogrel
Drug: Clopidogrel
single oral administration of 300mg of clopidogrel
Other Name: Plavix
Drug: Cilostazol
single oral administration of 100mg cilostazol
Other Name: Pletaal
Drug: Clopidogrel/Cilostazol
single oral administration of 300mg clopidogrel and 100mg cilostazol
Other Name: Plavix/Pletaal
Active Comparator: Cilostarole
single oral administration of 100mg of cilostazole
Drug: Clopidogrel
single oral administration of 300mg of clopidogrel
Other Name: Plavix
Drug: Cilostazol
single oral administration of 100mg cilostazol
Other Name: Pletaal
Drug: Clopidogrel/Cilostazol
single oral administration of 300mg clopidogrel and 100mg cilostazol
Other Name: 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 Name: Plavix
Drug: Cilostazol
single oral administration of 100mg cilostazol
Other Name: Pletaal
Drug: Clopidogrel/Cilostazol
single oral administration of 300mg clopidogrel and 100mg cilostazol
Other Name: Plavix/Pletaal

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subject whose CYP2C19 genotype was determined

Exclusion Criteria:

  • Subject who has abnormal laboratory test results
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01482117


Sponsors and Collaborators
Inje University
Investigators
Principal Investigator: Jae-Gook Shin, MD, PhD Inje University
  More Information

Responsible Party: Jae-Gook Shin, Department of Pharmacology and Pharmacogenomics Research Center, Inje University
ClinicalTrials.gov Identifier: NCT01482117     History of Changes
Other Study ID Numbers: 10-105
First Submitted: November 26, 2011
First Posted: November 30, 2011
Last Update Posted: June 3, 2013
Last Verified: May 2013

Keywords provided by Jae-Gook Shin, Inje University:
CYP2C19
CYP3A5
Clopidogrel
Cilostazol
Healthy

Additional relevant MeSH terms:
Clopidogrel
Cilostazol
Ticlopidine
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors