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

This study has been completed.

First Received: February 29, 2008 Last Updated: March 7, 2008 History of Changes

Sponsor:	POZEN
Information provided by:	POZEN
ClinicalTrials.gov Identifier:	NCT00632086

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: PA32540 Drug: aspirin component of PA32540 Drug: Ecotrin	Phase I

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
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

Resource links provided by NLM:

Drug Information available for: Acetylsalicylic acid Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by POZEN:

Estimated Enrollment:	36
Study Start Date:	February 2008
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Single oral dose of 325 mg aspirin administered as PA32540	Drug: PA32540
2: Experimental aspirin core	Drug: aspirin component of PA32540 The 325 mg aspirin component of PA32540
3: Active Comparator active	Drug: Ecotrin 325 mg Ecotrin

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Standard for PK

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Pozen ( Connie Powers )
Study ID Numbers:	PA32540-104
Study First Received:	February 29, 2008
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00632086 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by POZEN:

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Hematologic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions
Fibrin Modulating Agents

Aspirin
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Ulcer Agents
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010