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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00632086

Enrollment

Registered

2008-03-10

Start date

2008-02-29

Completion date

2008-02-29

Last updated

2008-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Brief summary

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

Interventions

DRUGPA32540

DRUGaspirin component of PA32540

The 325 mg aspirin component of PA32540

DRUGEcotrin

325 mg Ecotrin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Standard for PK

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026