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

Information source: Pozen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: PA32540 (Drug); aspirin component of PA32540 (Drug); Ecotrin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pozen

Summary

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

Clinical Details

Official title: 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

Study design: Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Standard for PK

- Ages 18-55 years old

- Males and females

Exclusion Criteria:

- Standard for PK

Locations and Contacts

Additional Information

Starting date: February 2008
Ending date: February 2008
Last updated: March 7, 2008

Page last updated: June 20, 2008

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