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

Sponsored by:	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

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:

Study placed in the following topic categories:

Anti-Inflammatory Agents
Cyclooxygenase Inhibitors
Omeprazole
Fibrinolytic Agents
Healthy
Cardiovascular Agents
Fibrin Modulating Agents

Aspirin
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Platelet Aggregation Inhibitors
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents

Additional relevant MeSH terms:

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

Aspirin
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
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 September 10, 2009