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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00632086
First Posted: March 10, 2008
Last Update Posted: March 10, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
POZEN
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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:


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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Responsible Party: Connie Powers, Pozen
ClinicalTrials.gov Identifier: NCT00632086     History of Changes
Other Study ID Numbers: PA32540-104
First Submitted: February 29, 2008
First Posted: March 10, 2008
Last Update Posted: March 10, 2008
Last Verified: February 2008

Keywords provided by POZEN:
PK

Additional relevant MeSH terms:
Aspirin
Omeprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors