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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: September 5, 2008
Last updated: December 19, 2008
Last verified: December 2008
A pharmacokinetic study evaluating naproxen and esomeprazole blood levels in 4 treatments, each containing one or both components.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • To evaluate the safety of each of the single-dose treatments [ Time Frame: Entire study duration (48 days) ] [ Designated as safety issue: Yes ]

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.

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00749385

United States, Texas
Austin, Texas, United States, 78744
Sponsors and Collaborators
  More Information

Responsible Party: David Taylor, POZEN
ClinicalTrials.gov Identifier: NCT00749385     History of Changes
Other Study ID Numbers: PN400-114 
Study First Received: September 5, 2008
Last Updated: December 19, 2008
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 26, 2016