CClinicalTrials.gg
CompletedNCT00632086Updated Mar 10, 2008

Evaluate Relative Bioavailability of PA32540 (Asa/Omeprazole), Its Aspirin Component, and Ecotrin® in Healthy Volunteers

A Phase 1 interventional study of PA32540 and aspirin component of PA32540 in Healthy, sponsored by POZEN. Completed. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-03-10.

Sponsored by POZEN · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

Study to determine a single dose bioavailablity of PA32540 is similar to EC aspirin 325 mg with respect to salicylic acid.

02

Conditions studied

  • Healthy

Keywords

  • PK
03

In context

Lead sponsor

POZEN is the lead sponsor of 26 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Standard for PK
  • Ages 18-55 years old
  • Males and females

Exclusion criteria

Exclusion Criteria:

  • Standard for PK
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    1

    Single oral dose of 325 mg aspirin administered as PA32540

    Drug: PA32540

  • Experimental
    2

    aspirin core

    Drug: aspirin component of PA32540

  • Active comparator
    3

    active

    Drug: Ecotrin

Interventions

  • DrugPA32540
  • Drugaspirin component of PA32540

    The 325 mg aspirin component of PA32540

  • DrugEcotrin

    325 mg Ecotrin

06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00632086
Lead sponsor
POZEN
First posted
Mar 10, 2008
Start date
Feb 2008
Primary completion
Feb 2008
Completion
Feb 2008
Last update
Mar 10, 2008

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.

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