A Parallel Group Study to Compare the Gastroprotective Effects of PA 325 Versus 81 mg Enteric Coated Aspirin

Exclusion Criteria

• •1. History of hypersensitivity to omeprazole or to another proton-pump inhibitor
• •2. History of allergic reaction or intolerance to aspirin or any NSAID and/or a history of NSAID-induced symptoms of asthma, rhinitis, and/or nasal polyps
• •3. Participation in any study of an investigational treatment in the 4 weeks before Day 1 dosing
• •4. Presence of uncontrolled acute or chronic medical illness, e.g. GI disorder, hypertension, diabetes, thyroid disorder, depression and/or infection that would endanger a subject if they were to participate in the study
• •5. GI disorder or surgery leading to impaired drug absorption
• •6. Evidence of uncontrolled, or unstable cardio- or cerebrovascular disorder, which in the investigator's opinion, would endanger a subject if he or she were to participate in the study
• •7. Schizophrenia or bipolar disorder
• •8. Use of any concomitant medication not approved by the study physician during the washout period and during the study conduct
• •9. Serious blood coagulation disorder, including use of systemic anticoagulants
• •10. Subjects who donated 50 to 499 mL of blood within 30 days and more than 499 mL within 56 days prior to dosing
• •11. 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
• •12. Baseline endoscopy showing any gastric or duodenal mucosal abnormality (hemorrhages, ulcers or erosions)
• •13. Gastric pH \> 3 at Day - 1 endoscopy
• •14. Screening laboratory alanine transaminase (ALT) or aspartate transaminase (AST) value \> 2 times the upper limit of normal
• •15. Estimated creatinine clearance \< 30 ml/min at screening
• •16. Other than noted specifically, any screening laboratory value that is clinically significant in the investigator's opinion and would endanger a subject if he or she were to participate in the study
• •17. History of hepatitis B or C, a positive test for hepatitis B surface antigen, hepatitis C antibody, a history of HIV infections, or demonstration of HIV antibodies
• •18. 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
• •19. Subjects who have previously been a screen failure in this study
• •20. 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
• •21. 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
• •22. Positive illicit drug screen