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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jae-Gook Shin, Inje University
ClinicalTrials.gov Identifier:
NCT01482117
First received: November 26, 2011
Last updated: December 21, 2011
Last verified: December 2011
History of Changes
  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
Healthy Volunteers
 Drug: Clopidogrel
Drug: Cilostazol
Drug: Clopidogrel/Cilostazol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: 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:

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Further study details as provided by Inje University:

Primary Outcome Measures:
  • Maximum concentration(Cmax), Area under the concentration(AUC), Inhibition of platelet aggregation(IPA) [ Time Frame: up to 24 hours ] [ Designated as safety issue: Yes ]
    9 or 11 point blood sampling according to the interventions


Estimated Enrollment: 27
Study Start Date: November 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EM
CYP2C19 extensive metabolizer
 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: IM
CYP2C19 intermediate metabolizer
 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: PM
CYP2C19 poor metabolizer
 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

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482117

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

No publications provided

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
Study First Received: November 26, 2011
Last Updated: December 21, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Inje University:
CYP2C19
CYP3A5
Clopidogrel
Cilostazol
Healthy

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

ClinicalTrials.gov processed this record on May 16, 2013