Phase I PA8140-102 Bioavailability Study: pharmacokinetics of aspirin/omeprazole [PA 8140] vs enteric-coated aspirin

Trial Profile

Phase I PA8140-102 Bioavailability Study: pharmacokinetics of aspirin/omeprazole [PA 8140] vs enteric-coated aspirin

Completed
Phase of Trial: Phase I

Latest Information Update: 09 Jan 2017

At a glance

  • Drugs Aspirin/omeprazole (Primary) ; Aspirin
  • Indications Cardiovascular disorders; Embolism and thrombosis; Gastric ulcer; NSAID-induced ulcer
  • Focus Pharmacokinetics; Registrational
  • Most Recent Events

    • 09 Jan 2017 According to an Aralez Pharmaceuticals Inc. media release, the company has submitted a Marketing Authorization Application (MAA) to the EMA for PA10040 (YOSPRALA) for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers based on results from three trials (CTPs 700036117, 700048158 and 700225598).
    • 15 Mar 2016 According to an Aralez Pharmaceuticals media release, the company has resubmitted to the US FDA the NDA for its investigational candidate, YOSPRALA (PA32540/PA8140) for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
    • 29 May 2013 The US FDA has accepted for review POZEN's NDA for PA 32540/PA 8140, according to a POZEN media release.
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