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Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations

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ClinicalTrials.gov Identifier: NCT00692055
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : September 5, 2008
Sponsor:
Information provided by:
POZEN

Brief Summary:
We will evaluate the bioavailability of naproxen 375 mg in two formulations

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations
Study Start Date : June 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
PN400
Drug: PN400
naproxen 375 mg / esomeprazole 20 mg

Active Comparator: 2
naproxen 375 mg
Drug: Naproxen
naproxen 375 mg




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


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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 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 ClinicalTrials.gov identifier (NCT number): NCT00692055


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

Responsible Party: David Taylor, POZEN
ClinicalTrials.gov Identifier: NCT00692055     History of Changes
Other Study ID Numbers: PN400-105
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: September 5, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Naproxen
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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action