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.

Trial Profile

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.

Completed
Phase of Trial: Phase I

Latest Information Update: 31 May 2011

At a glance

  • Drugs Esomeprazole; Esomeprazole/naproxen; Naproxen
  • Indications Arthritis; Musculoskeletal pain; NSAID-induced gastrointestinal damage
  • Focus Pharmacokinetics
  • Sponsors POZEN
  • Most Recent Events

    • 31 May 2011 Results published in the Journal of Clinical Pharmacology.
    • 31 Dec 2008 Status changed from active, no longer recruiting to completed.
    • 26 Sep 2008 New trial record.
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