An open-label, single-dose, partially-randomized crossover third pivotal bioequivalence study of oxycodone/naltrexone (ELI 201) in healthy volunteers

Trial Profile

An open-label, single-dose, partially-randomized crossover third pivotal bioequivalence study of oxycodone/naltrexone (ELI 201) in healthy volunteers

Recruiting
Phase of Trial: Phase I

Latest Information Update: 03 Dec 2014

At a glance

  • Drugs Oxycodone/naltrexone (Primary) ; Oxycodone
  • Indications Pain
  • Focus Pharmacokinetics; Registrational
  • Most Recent Events

    • 03 Dec 2014 Results published in an Elite Pharmaceuticals media release.
    • 03 Dec 2014 Primary endpoint has been met (bioavailability and bioequivalence of oxycodone/naltrexone controlled-release capsules to oxycodone controlled-release tablet), according to an Elite Pharmaceuticals media release.
    • 26 Aug 2014 New trial record
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