Status:
COMPLETED
To Compare the Gastroprotective Effects and Pharmacokinetic Profile of PA Versus Enteric-Coated Aspirin
Lead Sponsor:
POZEN
Conditions:
Healthy
Eligibility:
All Genders
50-75 years
Phase:
PHASE1
Brief Summary
Primary: To compare the gastroprotective effects of a once-daily dose of PA 325 combination tablet combining 325 mg pH sensitive aspirin and 20 mg immediate release omeprazole versus a once-daily dose...
Detailed Description
PA 325 is proposed for the reduction in the risk of aspirin-associated gastrointestinal (GI) adverse events in patients requiring daily aspirin. This study is designed as a Proof of Concept study to e...
Eligibility Criteria
Inclusion
- A subject will be eligible for inclusion in this study if all of the following criteria apply:
- Subject is a male or non-pregnant female
- Subject is 50-75 years of age
- Subject does not currently smoke
- Physical status within normal limits of age and consistent with observations at screening
- BMI of 20-30 kg/m2
- Female subjects are eligible for participation in the study if they are of:
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,
- Childbearing potential, have a negative pregnancy test (urine) at screening, and at least one of the following applies or is agreed to by the subject:
- Complete abstinence from intercourse for at least 14 days prior to first dose of study medication, throughout the study, and for 30 days after completion of the study
- Female sterilization or sterilization of male partner; or,
- Hormonal contraception by oral route, implant, injectable, vaginal ring; or,
- Any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1% per year;
- Double barrier method (2 physical barriers or 1 physical barrier plus spermicide); or
- Any other method with published data showing that the lowest expected failure rate is less than 1% per year
- Each subject must be able to understand and comply with study procedures required of a subject and is able and willing to provide written informed consent prior to any study procedures being performed
Exclusion
- History of hypersensitivity to omeprazole or to another proton-pump inhibitor
- History of allergic reaction or intolerance to aspirin or any NSAIDs and/or subject has a history of NSAID-induced symptoms of asthma, rhinitis, and/or nasal polyps
- Participation in any study of an investigational treatment in the 4 weeks before Day 1 dosing
- Presence of uncontrolled acute or chronic medical illness, e.g. gastrointestinal disorder, diabetes, hypertension, thyroid disorder, depression and/or infection that would endanger a subject if they were to participate in the study
- Gastrointestinal disorder or surgery leading to impaired drug absorption
- Evidence of uncontrolled, or unstable cardio- or cerebrovascular disorder, which in the investigator's opinion would endanger a subject if they were to participate in the study
- Schizophrenia or bipolar disorder
- Use of any concomitant medication not approved by the study physician during the washout period and during the study conduct
- Serious blood coagulation disorder including use of systemic anticoagulants
- Subjects who donated 50 to 499 mL of blood within 30 days and more than 499 mL within 56 days prior to dosing
- Subjects who, through completion of the study, would have donated in excess of:
- 500 mL of blood in 14 days;
- 1,500 mL of blood in 180 days;
- 2,500 mL of blood in 1 year.
- Baseline endoscopy showing any gastric or duodenal mucosal abnormality (hemorrhages, ulcers or erosions)
- Gastric pH \> 3 at screening
- Screening laboratory value for ALT, AST \>2 times the upper limit of normal
- Estimated creatinine clearance \< 30 ml/min
- Other than noted specifically, any screening laboratory value that is clinically significant in the investigator's opinion and would endanger a subject if they were to participate in the study
- History of hepatitis B or C, a positive test for hepatitis B surface antigen, hepatitis C antibody, a history of HIV infection, or demonstration of HIV antibodies
- History of malignancy, treated or untreated, within the past 5 years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin
- Subjects who have previously been a screen failure in this study
- Subject has excessive alcohol use (\> 2 units per day on average; for example 2 bottles of beer, two glasses of wine, 2 ounces of liquor/spirits), or recent history (in the past 3 months) suggestive of alcohol or drug abuse or dependence.
- Subject has ingested grapefruit or grapefruit juice within 10 days of dosing or will ingest grapefruit or grapefruit juice during the duration of the study.
- Positive illicit drug screen
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00442052
Start Date
November 1 2006
End Date
January 1 2007
Last Update
March 1 2007
Active Locations (2)
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1
POZEN
Chapel Hill, North Carolina, United States, 27517
2
MDS Pharma Services
Montreal, Quebec, Canada, H4R2N6