NCT01482117

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 30, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

June 3, 2013

Status Verified

May 1, 2013

Enrollment Period

2 months

First QC Date

November 26, 2011

Last Update Submit

May 31, 2013

Conditions

Interaction

Keywords

CYP2C19CYP3A5ClopidogrelCilostazolHealthy

Outcome Measures

Primary Outcomes (1)

  • Maximum concentration(Cmax), Area under the concentration(AUC), Inhibition of platelet aggregation(IPA)

    9 or 11 point blood sampling according to the interventions

    up to 24 hours

Study Arms (3)

Clopidogrel

ACTIVE COMPARATOR

single oral administration of 300mg of clopidogrel

Drug: ClopidogrelDrug: CilostazolDrug: Clopidogrel/Cilostazol

Cilostarole

ACTIVE COMPARATOR

single oral administration of 100mg of cilostazole

Drug: ClopidogrelDrug: CilostazolDrug: Clopidogrel/Cilostazol

Clopidogrel/Cilostazol

ACTIVE COMPARATOR

single oral administration of 300mg clopidogrel and 100mg cilostazol

Drug: ClopidogrelDrug: CilostazolDrug: Clopidogrel/Cilostazol

Interventions

ClopidogrelDRUG

single oral administration of 300mg of clopidogrel

Also known as: Plavix
CilostaroleClopidogrelClopidogrel/Cilostazol
CilostazolDRUG

single oral administration of 100mg cilostazol

Also known as: Pletaal
CilostaroleClopidogrelClopidogrel/Cilostazol
Clopidogrel/CilostazolDRUG

single oral administration of 300mg clopidogrel and 100mg cilostazol

Also known as: Plavix/Pletaal
CilostaroleClopidogrelClopidogrel/Cilostazol

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subject whose CYP2C19 genotype was determined

You may not qualify if:

  • Subject who has abnormal laboratory test results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

ClopidogrelCilostazol

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTetrazolesAzolesQuinolines

Study Officials

  • Jae-Gook Shin, MD, PhD

    Inje University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Pharmacology and Pharmacogenomics Research Center

Study Record Dates

First Submitted

November 26, 2011

First Posted

November 30, 2011

Study Start

November 1, 2011

Primary Completion

January 1, 2012

Study Completion

February 1, 2012

Last Updated

June 3, 2013

Record last verified: 2013-05