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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT00620802
Eligibility Criteria:
Inclusion Criteria:
* Healthy males and females. Women of childbearing potential must have a negative pregnancy test prior to enrollment and agree to use two methods of effective barrier contraception, or a hormonal contraceptive to prevent pregnancy throughout the study.
* Able to comply with study procedures, which includes returning to the Phase I unit for all scheduled visits and procedures.
* Abstinence from tobacco use (including smoking cessation products containing nicotine) for 90 days prior to study entry, with agreement to abstain from tobacco/nicotine use throughout the study.
* Agreement to abstain from alcohol and caffeine ingestion from 72 h before dosing and throughout each dosing period.
* Able to give informed consent, and subject has signed and dated a written consent form approved by the IRB.
Exclusion Criteria:
* Hypersensitivity to clopidogrel, omeprazole, or related drugs including inactive ingredients.
* BMI (body mass index) outside the range of 19-30 kg/m2.
* At screening, body weight less than 50 kg if male or 45 kg if female.
* Clinically significant abnormal findings on physical examination, clinical laboratory tests or ECG at screening.
* History of hypertension or 5-minute sitting screening BP ≥160/100 mmHg on measurements repeated twice.
* History of diabetes mellitus, renal failure, acute or chronic liver disease, including acute or chronic hepatitis, or cirrhosis.
* Positive HIV-1 antibody, hepatitis B surface antigen or hepatitis C antibody screening test.
* History of any clinically significant medical or psychiatric condition.
* Difficulty in swallowing medication, or any known or suspected gastrointestinal abnormality that may affect drug absorption.
* Participation in a previous clinical trial within 30 days prior to enrollment (check-in on Day -1 for Visit 2).
* Blood donation of ≥ 1 pint within 30 days or plasma donation within 14 days prior to enrollment (check-in on Day -1 for Visit 2).
* Use of any prescription or over-the-counter medications or ingestion of herbal drugs/dietary supplements including vitamins and minerals within 14 days prior to enrollment (check-in on Day -1 for Visit 2). Hormonal contraceptives are allowed.
* Subject is not willing to refrain from drinking grapefruit juice or eating grapefruit throughout study participation.
* Subject is an active illicit drug user or has a history of illicit drug use within the previous 12 months.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00620802
Study Brief:
Protocol Section:
NCT00620802