Evaluate Relative Bioavailability of PA32540 (Asa/Omeprazole), Its Aspirin Component, and Ecotrin® in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT00632086
- Lead Sponsor
- POZEN
- Brief Summary
Study to determine a single dose bioavailablity of PA32540 is similar to EC aspirin 325 mg with respect to salicylic acid.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- Standard for PK
- Ages 18-55 years old
- Males and females
Exclusion Criteria
- Standard for PK
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 PA32540 Single oral dose of 325 mg aspirin administered as PA32540 2 aspirin component of PA32540 aspirin core 3 Ecotrin active
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What is the mechanism of action of omeprazole in mitigating aspirin-induced gastric irritation in NCT00632086?
How does the bioavailability of PA32540 compare to standard enteric-coated aspirin in healthy volunteers?
Are there specific biomarkers that correlate with enhanced absorption of aspirin formulations like PA32540?
What are the potential adverse events associated with PA32540 and how do they compare to Ecotrin®?
How does the pharmacokinetic profile of PA32540 influence its efficacy as an antiplatelet agent compared to conventional aspirin?