KCT0000429
Recruiting
未知
Clinical trial to evaluate the influence of genotype of drug metabolizing enzyme or transporter and drug-drug interactions on thepharmacokinetics/pharmacodynamics of clopidogrel in healthy volunteers
ConditionsNot Applicable
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not Applicable
- Sponsor
- Seoul National University
- Enrollment
- 18
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •1\. Presence or history of hypersensitivity or allerig reactions to drugs including investirational 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.
- •10\.Use of grapefruit juice within 1 week before first dose.
Outcomes
Primary Outcomes
Not specified
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