Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations

This study has been completed.
Information provided by:
POZEN Identifier:
First received: June 4, 2008
Last updated: September 4, 2008
Last verified: September 2008
We will evaluate the bioavailability of naproxen 375 mg in two formulations

Condition Intervention Phase
Drug: PN400
Drug: Naproxen
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations

Resource links provided by NLM:

Further study details as provided by POZEN:

Primary Outcome Measures:
  • To assess and compare the pharmacokinetics bioavailability of a single oral dose of naproxen administered in two formulations [ Time Frame: 72-hour PK ]

Secondary Outcome Measures:
  • To evaluate the safety of the two treatments [ Time Frame: entire study duration ]

Enrollment: 30
Study Start Date: June 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: PN400
naproxen 375 mg / esomeprazole 20 mg
Active Comparator: 2
naproxen 375 mg
Drug: Naproxen
naproxen 375 mg


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy male or non-pregnant female subjects between 18-55 years as well as other standard inclusion criteria for a study of this nature

Exclusion Criteria:

  • Standard exclusion criteria for a study of this nature
  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.

Please refer to this study by its identifier: NCT00692055

United States, Texas
Austin, Texas, United States
Sponsors and Collaborators
  More Information

Responsible Party: David Taylor, POZEN Identifier: NCT00692055     History of Changes
Other Study ID Numbers: PN400-105
Study First Received: June 4, 2008
Last Updated: September 4, 2008

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 23, 2017