CG106 is a Phase I open-label, randomized, multiple-dose, two-way crossover study to
characterize the pharmacodynamics and pharmacokinetics of the investigational fixed-dose
combination product CGT 2168 (clopidogrel, 75 mg and omeprazole, 20 mg) relative to Plavix®
(clopidogrel, 75 mg).
Healthy volunteer subjects will undergo two dosing periods. In each 7-day dosing period,
subjects will receive oral doses of study drug consisting of open-label CGT 2168 or Plavix®
in the order determined by the randomization schedule. Each period of dose administration
will be separated by a two-week washout period. Study exit will occur 1 week after Dosing
Period 2. The expected total duration of participation is 8 weeks (56 days), including a
screening visit on or within 21 days prior to enrollment.
On the day before Day 1 and Day 7 in each dosing period, subjects will be admitted to the
Phase I unit. Blood samples to determine ADP-induced platelet aggregation will be collected
pre-dose on Day 1 and 2 h after dosing on Day 7. Plasma concentrations of clopidogrel
parent and clopidogrel carboxylic acid metabolite will also be measured pre-dose on Day 1
and pre-dose and serially after dosing on Day 7.
- 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.
- Hypersensitivity to clopidogrel, omeprazole, or related drugs including inactive
- 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
- 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.