Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT01503658
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 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.
* 10.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.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT01503658
Study Brief:
Protocol Section:
NCT01503658