Status:
COMPLETED
Pharmacodynamics of CGT 2168 Compared With Plavix®
Lead Sponsor:
Cogentus Pharmaceuticals
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 21...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00620802
Start Date
November 1 2007
End Date
May 1 2008
Last Update
August 26 2008
Active Locations (1)
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1
Quintiles Phase I Services
Overland Park, Kansas, United States, 66211