Status:
COMPLETED
A Parallel Group Study to Compare the Gastroprotective Effects of PA 325 Versus 81 mg Enteric Coated Aspirin
Lead Sponsor:
POZEN
Conditions:
Healthy
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief Summary
To compare the gastroprotective effects of a once-daily dose of PA 325 combination tablet
Detailed Description
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...
Eligibility Criteria
Inclusion
- Subject is a male or a female who is not pregnant or is not lactating. A female is eligible to enter and participate in this study if she is of:
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,
- Childbearing potential has a negative pregnancy test 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
- Subject is \> 50 years of age inclusive at the time of dosing
- Subject does not currently smoke and has not smoked for at least 3 months
- The subject's physical status is within normal limits of age and consistent with observations at screening
- The subject's Body Mass Index (BMI) is between 20-30 kg/m2
- 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 NSAID and/or 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. GI disorder, hypertension, diabetes, thyroid disorder, depression and/or infection that would endanger a subject if they were to participate in the study
- GI 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 he or she 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 Day - 1 endoscopy
- Screening laboratory alanine transaminase (ALT) or aspartate transaminase (AST) value \> 2 times the upper limit of normal
- Estimated creatinine clearance \< 30 ml/min at screening
- 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
- 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
- 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 :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00441519
Start Date
February 1 2007
End Date
April 1 2007
Last Update
January 12 2009
Active Locations (2)
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1
POZEN
Chapel Hill, North Carolina, United States, 27517
2
MDS Pharma Services
Montreal, Quebec, Canada, H4R2N6