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Sponsored by: |
Cogentus Pharmaceuticals |
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Information provided by: | Cogentus Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00620802 |
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 | Intervention | Phase |
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Healthy |
Drug: CGT-2168 Drug: Plavix |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Phase I, Open-Label, Randomized, Multiple-Dose, Two-Way Crossover Study of the Pharmacodynamics of CGT 2168 Compared With Plavix® |
Enrollment: | 60 |
Study Start Date: | November 2007 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg)
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Drug: CGT-2168
(CGT-2168, one capsule each daily)
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B: Active Comparator
Plavix (clopidogrel 75 mg)
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Drug: Plavix
(clopidogrel, 75 mg)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Kansas | |
Quintiles Phase I Services | |
Overland Park, Kansas, United States, 66211 |
Study Director: | Pablo Lapuerta, MD | Cogentus Pharmaceuticals |
Responsible Party: | Cogentus Pharmaceuticals ( Pablo Lapuerta, MD ) |
Study ID Numbers: | CG106 |
Study First Received: | February 12, 2008 |
Last Updated: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00620802 |
Health Authority: | United States: Food and Drug Administration |
Platelet function testing Healthy volunteers |
Clopidogrel Healthy |
Therapeutic Uses Hematologic Agents Platelet Aggregation Inhibitors Pharmacologic Actions |