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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
(CGT-2168, one capsule each daily)
(clopidogrel, 75 mg)
Quintiles Phase I Services
Overland Park, Kansas, United States
The primary endpoint of this study is inhibition of platelet aggregation (IPA) based on maximum platelet aggregation (MPA) to 5 and 20 µM ADP after 7 days daily dosing with CGT-2168 compared to Plavix®.
Time frame: 7 days
Residual aggregation, measured 10 min after the addition of 20 and 5 µM ADP, after 7 days daily dosing with CGT 2168 compared to Plavix®.
Time frame: 7 days
Plasma PK measures of clopidogrel (parent drug and carboxylic acid metabolite) with CGT 2168 compared to Plavix®.
Time frame: 7 days
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