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Clinical Trial to Evaluate the Influence of Genotype on the Pharmacokinetics/Pharmacodynamics of Clopidogrel

NCT01503658 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2012-06-19

No results posted yet for this study

Summary

This study has an open-label, five-period, single-sequence design. The purpose of this study is as follows;

1. Primary

* To evaluate the influence of genotype of drug metabolizing enzyme or transporter on the pharmacokinetics/pharmacodynamics of clopidogrel
* To evaluate the influence of aspirin on the pharmacokinetics/pharmacodynamics of clopidogrel
2. Secondary

* To explore the representative biomarkers for the variable pharmacokinetics/pharmacodynamics of clopidogrel
* To evaluate the influence of genotype of drug metabolizing enzyme or transporter on the drug-drug interactions between aspirin and clopidogrel
* To explore the representative biomarkers for the drug-drug interactions between aspirin and clopidogrel

Conditions

  • Influence of Genotype of Drug Metabolizing Enzyme or Transporter on the Pharmacokinetics/Pharmacodynamics of Clopidogrel
  • Influence of Aspirin on the Pharmacokinetics/Pharmacodynamics of Clopidogrel

Interventions

DRUG

Clopidogrel+Aspirin

Clopidogrel 75 mg, Aspirin 100 mg

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • In-Jin Jang, MD · Seoul National University Hospital

Study Design

Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01503658 on ClinicalTrials.gov