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.
Phase of Trial: Phase I
Latest Information Update: 07 Jul 2017
At a glance
- Drugs Oxycodone/naltrexone (Primary) ; Oxycodone
- Indications Pain; Postoperative pain
- Focus Pharmacokinetics
- 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