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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PA32540; Drug: aspirin component of PA32540; Drug: Ecotrin

• 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

Study Timeline

• Status Verified: 2008-02
• Study Start: 2008-02
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Study First Submitted: 2008-02-29
• Study First Submitted QC: 2008-03-07
• Last Update Submitted: 2008-03-07
• Study First Posted: 2008-03-10
• Last Update Posted: 2008-03-10

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