Pharmacodynamics of CGT 2168 Compared With Plavix®
Status:
Completed
Trial end date:
2008-05-01
Target enrollment:
Participant gender:
Summary
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.