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

This study has been completed.
Sponsor:
Information provided by:
POZEN
ClinicalTrials.gov Identifier:
NCT00632086
First received: February 29, 2008
Last updated: March 7, 2008
Last verified: February 2008
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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

Keywords provided by POZEN:
PK

Additional relevant MeSH terms:
Aspirin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014