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Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations

This study has been completed.
Sponsor:
Information provided by:
POZEN
ClinicalTrials.gov Identifier:
NCT00665743
First received: April 23, 2008
Last updated: June 9, 2008
Last verified: June 2008
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT00665743

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

No publications provided

Responsible Party: David Taylor, Pozen
ClinicalTrials.gov Identifier: NCT00665743     History of Changes
Other Study ID Numbers: PN400-102
Study First Received: April 23, 2008
Last Updated: June 9, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Esomeprazole
Naproxen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Ulcer Agents
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gastrointestinal Agents
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Proton Pump Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014