Dose Proportionality and the Effects of Food on Bioavailability of an Immediate-Release Oxycodone Hydrochloride Tablet Designed to Discourage Tampering and Its Relative Bioavailability Compared With a Marketed Oxycodone Tablet Under Fed Conditions: A Single-Dose, Randomized, Open-Label, 5-Way Crossover Study in Healthy Volunteers

摘要

Background: An immediate-release oxycodone hydrochloride formulation (IRO-A) indicated for moderate to severe pain was designed (by adding functional excipients) to discourage tampering associated with intranasal and intravenous abuse of prescription opioids. Objectives: The primary objective of this study was to determine the dose proportionality of oxycodone in IRO-A tablets under fasted conditions. Secondary objectives were to assess food effects on the pharmacoki-netics of IRO-A tablets, to compare the relative bio-availability of oxycodone in IRO-A tablets versus marketed oxycodone hydrochloride (IRO) tablets under fed conditions and to evaluate the single-dose safety profile of the IRO-A tablets in healthy volunteers pretreated with naltrexone.