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Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00665743
First Posted: April 24, 2008
Last Update Posted: June 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
We will evaluate the bioavailability of naproxen 500 mg administered as three dfferent formulations.

Condition Intervention Phase
Arthritis Drug: PN400 Drug: naproxen Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-Label, Randomized, 3-Way Crossover Study to Evaluate the Relative Bioavailability of a Single Oral Dose of Naproxen 500 mg Administered as PN 400 (Naproxen / Esomeprazole), as the [Active Comparator 1], or as [Active Comparator 2] in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by POZEN:

Primary Outcome Measures:
  • To assess and compare the pharmacokinetics and relative bioavailability of a single oral dose of naproxen 500 mg administered in 3 formulations [ Time Frame: 72-hour PK ]

Secondary Outcome Measures:
  • To evaluate the safety of the 3 treatments [ Time Frame: entire study duration ]

Estimated Enrollment: 30
Study Start Date: March 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
PN400 (naproxen/esomeprazole)
Drug: PN400
naproxen 500 mg /esomeprazole 20 mg
Active Comparator: B
naproxen 500 mg
Drug: naproxen
naproxen 500 mg tablet
Active Comparator: C
naproxen 500 mg
Drug: naproxen
naproxen 500 mg

  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:

  • Healthy male or non-pregnant female subjects between 18-55 years of age 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665743


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

Responsible Party: David Taylor, Pozen
ClinicalTrials.gov Identifier: NCT00665743     History of Changes
Other Study ID Numbers: PN400-102
First Submitted: April 23, 2008
First Posted: April 24, 2008
Last Update Posted: June 10, 2008
Last Verified: June 2008

Additional relevant MeSH terms:
Esomeprazole
Naproxen
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
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
Gout Suppressants
Cyclooxygenase Inhibitors