We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Pharmacokinetic (PK) Study Evaluating Naproxen and Esomeprazole Plasma Levels

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00749385
First Posted: September 9, 2008
Last Update Posted: December 23, 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
A pharmacokinetic study evaluating naproxen and esomeprazole blood levels in 4 treatments, each containing one or both components.

Condition Intervention Phase
Arthritis Drug: PN 400 Drug: EC naproxen plus EC esomeprazole Drug: EC naproxen Drug: EC esomeprazole Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomized, Open-Label, 4-Way Crossover Study to Evaluate Naproxen and Esomeprazole Plasma Levels in Healthy Subjects Following Oral Administration of PN 400, Enteric-Coated Naproxen 500mg Plus Enteric-Coated Esomeprazole 20mg, Enteric-Coated Naproxen 500mg Alone, and Enteric-Coated Esomeprazole 20mg Alone.

Resource links provided by NLM:


Further study details as provided by POZEN:

Primary Outcome Measures:
  • To assess the single-dose pharmacokinetics and relative bioavailability of esomeprazole in PN 400 (naproxen 500mg / esomeprazole 20mg), the enteric-coated (EC) naproxen 500mg plus EC esomeprazole 20mg and the EC esomeprazole 20mg alone treatments [ Time Frame: 12-72 hour PK assessments ]

Secondary Outcome Measures:
  • To assess the single-dose pharmacokinetics and relative bioavailability of naproxen in PN 400 (naproxen 500mg / esomeprazole 20mg, the EC naproxen 500mg plus EC esomeprazole 20mg, and the EC naproxen 500mg alone treatments. [ Time Frame: 72-hour PK assessments ]
  • To evaluate the safety of each of the single-dose treatments [ Time Frame: Entire study duration (48 days) ]

Enrollment: 40
Study Start Date: August 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
PN 400
Drug: PN 400
A single tablet containing delayed-release naproxen (500mg) plus immediate-release esomeprazole (20mg)
Active Comparator: 2
Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule(20mg)
Drug: EC naproxen plus EC esomeprazole
Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule (20mg)
Other Name: EC Naprosyn and Nexium
Active Comparator: 3
Enteric-coated naproxen tablet (500mg)
Drug: EC naproxen
Enteric-coated naproxen tablet (500mg)
Other Name: EC Naprosyn
Active Comparator: 4
EC esomeprazole capsule (20mg)
Drug: EC esomeprazole
Enteric-coated esomeprazole capsule (20mg)
Other Name: Nexium

Detailed Description:
This study is being conducted to assess the relative bioavailability of naproxen and esomeprazole from a single dose of PN 400 (delayed-release naproxen 500mg / immediate-release esomeprazole 20mg), enteric-coated naproxen 500mg co-administered with enteric-coated esomeprazole 20mg, enteric-coated naproxen 500mg administered alone, and enteric-coated esomeprazole 20mg administered alone.
  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 males and non-pregnant, non-lactating females who are either of non-childbearing potential or using an acceptable method of birth control.

Exclusion Criteria:

  • Standard exclusion criteria for a study of this nature - no significant medical conditions that might affect the interpretation of the PK data or compromise the safety of the subject.
  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): NCT00749385


Locations
United States, Texas
PPD
Austin, Texas, United States, 78744
Sponsors and Collaborators
POZEN
  More Information

Responsible Party: David Taylor, POZEN
ClinicalTrials.gov Identifier: NCT00749385     History of Changes
Other Study ID Numbers: PN400-114
First Submitted: September 5, 2008
First Posted: September 9, 2008
Last Update Posted: December 23, 2008
Last Verified: December 2008

Additional relevant MeSH terms:
Esomeprazole
Naproxen
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
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