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A pivotal, open-label, randomized, single-dose, three-way, crossover bioequivalence study to evaluate the relative comparative bioavailability and bioequivalence of the modified formulation of SequestOx to the original formulation and to a comparator product under fed conditions.

Trial Profile

A pivotal, open-label, randomized, single-dose, three-way, crossover bioequivalence study to evaluate the relative comparative bioavailability and bioequivalence of the modified formulation of SequestOx to the original formulation and to a comparator product under fed conditions.

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 07 Jul 2017

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At a glance

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

    • 07 Jul 2017 Top-line results published in an Elite Pharmaceuticals media release.
    • 25 May 2017 According to an Elite Pharmaceuticals media release, top-line results for this trial are expected in July 2017. Patient disqualification and subsequent subject recruitment issues extended the completion date for the study.
    • 20 Mar 2017 New trial record
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