Journal of Bioequivalence & Bioavailability

Joanne Salageanu

Publications

• Research Article
  Relative Bioavailability Study of an Abuse-Deterrent Formulation of Extended-Release Oxycodone with Sequestered Naltrexone (ALO-02) Versus Immediate-Release Oxycodone Tablets in Healthy Volunteers
  Author(s): Bimal Malhotra, Kyle Matschke, Candace Bramson, Qiang Wang and Joanne SalageanuBimal Malhotra, Kyle Matschke, Candace Bramson, Qiang Wang and Joanne Salageanu
  
  Background: ALO-02, an opioid formulation intended to deter abuse, comprising capsules filled with pellets of extended-release oxycodone hydrochloride, an opioid, surrounding sequestered naltrexone hydrochloride, an opioid antagonist. This study compared oxycodone pharmacokinetics following ALO-02 (oxycodone/naltrexone 40 mg/4.8 mg) versus immediate-release oxycodone (IRO) tablets (20 mg). Methods: This was an institutional review board–approved, open-label, single-dose, randomized, two-way crossover study in 14 healthy fasted adults (aged 18 to 55 years). Plasma concentrations of oxycodone, naltrexone, and 6-β-naltrexol were determined. Maximum plasma concentration (Cmax), area under the plasma concentrationtime profile from time 0 to infinity (AUCinf) and to the last quantifiable concentration (AUClast), time to Cmax (Tmax), and terminal half-life (t1/2) were determined. .. View More»
  DOI: 10.4172/jbb.1000202

  Abstract PDF