Evaluate Relative Bioavailability of PA32540 (Asa/Omeprazole), Its Aspirin Component, and Ecotrin® in Healthy Volunteers
A Phase 1, Open-Label, Randomized, 3-Way Crossover Study to Evaluate the Relative Bioavailability of a Single Oral Dose of Aspirin Administered as PA32540 (Aspirin/Omeprazole) or as the Aspirin Component of PA32540 or as Ecotrin® 325 mg in Healthy Volunteers
1 other identifier
interventional
36
0 countries
N/A
Brief Summary
Study to determine a single dose bioavailablity of PA32540 is similar to EC aspirin 325 mg with respect to salicylic acid.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Feb 2008
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 29, 2008
CompletedFirst Posted
Study publicly available on registry
March 10, 2008
CompletedMarch 10, 2008
February 1, 2008
Same day
February 29, 2008
March 7, 2008
Conditions
Keywords
Study Arms (3)
1
EXPERIMENTALSingle oral dose of 325 mg aspirin administered as PA32540
2
EXPERIMENTALaspirin core
3
ACTIVE COMPARATORactive
Interventions
Eligibility Criteria
You may qualify if:
- Standard for PK
- Ages 18-55 years old
- Males and females
You may not qualify if:
- Standard for PK
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- POZENlead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 29, 2008
First Posted
March 10, 2008
Study Start
February 1, 2008
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
March 10, 2008
Record last verified: 2008-02