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 of 325 mg enteric coated aspirin utilizing Lanza scores from endoscopy
findings in normal healthy volunteers.
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 of 325 mg enteric coated aspirin utilizing Lanza scores from endoscopy
findings in normal healthy volunteers.
Inclusion Criteria:
1. 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
2. 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
3. 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 Criteria:
1. History of hypersensitivity to omeprazole or to another proton-pump inhibitor
2. 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
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. gastrointestinal
disorder, diabetes, hypertension, thyroid disorder, depression and/or infection that
would endanger a subject if they were to participate in the study
5. Gastrointestinal 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 they 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 screening
14. Screening laboratory value for ALT, AST >2 times the upper limit of normal
15. Estimated creatinine clearance < 30 ml/min
16. 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
17. 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
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
