Pharmacodynamics of CGT 2168 Compared With Plavix®
|ClinicalTrials.gov Identifier: NCT00620802|
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : August 26, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: CGT-2168 Drug: Plavix||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Open-Label, Randomized, Multiple-Dose, Two-Way Crossover Study of the Pharmacodynamics of CGT 2168 Compared With Plavix®|
|Study Start Date :||November 2007|
|Primary Completion Date :||May 2008|
|Study Completion Date :||May 2008|
CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg)
(CGT-2168, one capsule each daily)
Active Comparator: B
Plavix (clopidogrel 75 mg)
(clopidogrel, 75 mg)
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00620802
|United States, Kansas|
|Quintiles Phase I Services|
|Overland Park, Kansas, United States, 66211|
|Study Director:||Pablo Lapuerta, MD||Cogentus Pharmaceuticals|