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
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:
Arthritis
Joint Diseases
Musculoskeletal Diseases
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 15, 2014