Clinical Trial to Evaluate the Influence of Genotype of Drug Metabolizing Enzyme or Transporter and Drug-drug Interactions on the Pharmacokinetics/Pharmacodynamics of Clopidogrel in Healthy Volunteers

Seoul National University Hospital1 site in 1 country18 target enrollmentJanuary 2012

Overview

Phase: Phase 4
Intervention: Clopidogrel+Aspirin
Conditions: Influence of Genotype of Drug Metabolizing Enzyme or Transporter on the Pharmacokinetics/Pharmacodynamics of Clopidogrel
Sponsor: Seoul National University Hospital
Enrollment: 18
Locations: 1
Primary Endpoint: Pharmacokinetics of Clopidogrel
Status: Completed
Last Updated: 13 years ago

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

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
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

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

May 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Sponsor

Responsible Party

Principal Investigator

In-Jin Jang, MD, PhD

Professor

Seoul National University Hospital

•Healthy male subjects aged 20 - 45 years.
•A body weight in the range of 50 kg (inclusive) - 90 kg (exclusive) and a body mass index (BMI) in the range 18.5 kg/m2 (inclusive) - 27 kg/m2 (inclusive).
•Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures.

•Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (clopidogrel or aspirin)
•Clinically relevant abnormal medical history that could interfere with the objectives of the study.
•A subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug.
•A subject whose lab test results are as follows; Platelet count or PT, aPTT \< 0.9 x lower limit of reference range of \> 1.1 x upper limit of reference range.
•A subject whose SBP is over 160 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg.
•Presence or history of drug abuse or positive result in urine drug screening test.
•Participation in other clinical trial within 2 months before first dose.
•Use of CYP inducer (ex. rifampin) within 4 weeks before first dose.
•Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication or vitamin substances within 1 week before first dose.
•10.Use of grapefruit juice within 1 week before first dose.