We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00692055
First Posted: June 6, 2008
Last Update Posted: September 5, 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 375 mg in two 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: Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations

Resource links provided by NLM:


Further study details as provided by POZEN:

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

Enrollment: 30
Study Start Date: June 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
PN400
Drug: PN400
naproxen 375 mg / esomeprazole 20 mg
Active Comparator: 2
naproxen 375 mg
Drug: Naproxen
naproxen 375 mg

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  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): NCT00692055


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

Responsible Party: David Taylor, POZEN
ClinicalTrials.gov Identifier: NCT00692055     History of Changes
Other Study ID Numbers: PN400-105
First Submitted: June 4, 2008
First Posted: June 6, 2008
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