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 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT01170533
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers aged between 18 and 75 years
Exclusion Criteria:
1. Known allergies to clopidogrel or omeprazole.
2. Blood dyscrasia or bleeding diathesis.
3. Recent antiplatelet treatment (\< 30 days) with a glycoprotein IIb/IIIa antagonist, thienopyridine (ticlopidine, clopidogrel), cilostazol or dipyridamole.
4. Treatment with other medications that may interfere with the CYP system (ketoconazole, itraconazole, diltiazem, erythromycin, clarithromycin, fluvoxamine, fluoxetine, nefazodone, or sertraline).
5. Platelet count \<100x106/microL.
6. Diabetes mellitus
7. History of coronary artery disease, gastrointestinal bleed, gastroesophageal reflux disease (GERD), cerebrovascular event or any active malignancy.
8. Active bleeding or hemodynamic instability.
9. Serum creatinine \>2mg/dL.
10. Baseline ALT \>2.5 times the upper limit of normal.
11. Pregnant females.
12. Patients taking omeprazole or any H2 antagonist or proton pump inhibitors
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01170533
Study Brief:
Protocol Section:
NCT01170533