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

POZEN

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Ecotrin; Drug: PA32540; Drug: aspirin component of PA32540

Study type: Interventional

Funder types: Industry

Identifiers

NCT00632086

PA32540-104

Details and patient eligibility

About

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

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Standard for PK

Trial design

36 participants in 3 patient groups

1

Experimental group

Description:

Single oral dose of 325 mg aspirin administered as PA32540

Treatment:

Drug: PA32540

2

Experimental group

Description:

aspirin core

Treatment:

Drug: aspirin component of PA32540

3

Active Comparator group

Description:

active

Treatment:

Drug: Ecotrin