Expired Study
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Overland Park, Kansas 66211


Purpose:

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.


Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - Hypersensitivity to clopidogrel, omeprazole, or related drugs including inactive ingredients. - 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 screening test. - 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.


NCT ID:

NCT00620802


Primary Contact:

Study Director
Pablo Lapuerta, MD
Cogentus Pharmaceuticals


Backup Contact:

N/A


Location Contact:

Overland Park, Kansas 66211
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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