Pharmacodynamics of CGT 2168 Compared With Plavix®

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.