Status:
COMPLETED
Clinical Trial to Evaluate the Influence of Genotype on the Pharmacokinetics/Pharmacodynamics of Clopidogrel
Lead Sponsor:
Seoul National University Hospital
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
Eligibility:
MALE
20-45 years
Phase:
PHASE4
Brief 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 trans...
Eligibility Criteria
Inclusion
- 1\. Healthy male subjects aged 20 - 45 years.
- 2\. 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).
- 3\. 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.
Exclusion
- 1\. Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (clopidogrel or aspirin)
- 2\. Clinically relevant abnormal medical history that could interfere with the objectives of the study.
- 3\. 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.
- 4\. 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.
- 5\. A subject whose SBP is over 160 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg.
- 6\. Presence or history of drug abuse or positive result in urine drug screening test.
- 7\. Participation in other clinical trial within 2 months before first dose.
- 8\. Use of CYP inducer (ex. rifampin) within 4 weeks before first dose.
- 9\. Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication or vitamin substances within 1 week before first dose.
- Use of grapefruit juice within 1 week before first dose.
- 11\. Blood donation during 2 months or apheresis during 1 month before the study.
- 12\. Use of alcohol over 21 units/weeks
- 13\. Smoking of more than 10 cigarettes/days within 3 months before first dose.
- 14\. Subject judged not eligible for study participation by investigator.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01503658
Start Date
January 1 2012
End Date
May 1 2012
Last Update
June 19 2012
Active Locations (1)
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1
Seoul National University Hospital Clinical Trials Center
Seoul, South Korea, 110-744