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Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations

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. Identifier: NCT00665743
Recruitment Status : Completed
First Posted : April 24, 2008
Last Update Posted : June 10, 2008
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Brief Summary:
We will evaluate the bioavailability of naproxen 500 mg administered as three dfferent formulations.

Condition or disease Intervention/treatment Phase
Arthritis Drug: PN400 Drug: naproxen Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Study Start Date : March 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. To evaluate the safety of the 3 treatments [ Time Frame: entire study duration ]

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

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

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 identifier (NCT number): NCT00665743

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United States, Texas
Austin, Texas, United States
Sponsors and Collaborators
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Responsible Party: David Taylor, Pozen Identifier: NCT00665743    
Other Study ID Numbers: PN400-102
First Posted: April 24, 2008    Key Record Dates
Last Update Posted: June 10, 2008
Last Verified: June 2008
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
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