Pharmacokinetic investigation of dose proportionality with a 24-hour controlled-release formulation of hydromorphone.

ABSTRACT:

Background

The purpose of this study was investigate the dose proportionality of a novel, once-daily, controlled-release formulation of hydromorphone that utilizes the OROS Push-Pull osmotic pump technology.

Methods

In an open-label, four-way, crossover study, 32 healthy volunteers were randomized to receive a single dose of OROS hydromorphone 8, 16, 32, and 64 mg, with a 7-day washout period between treatments. Opioid antagonism was provided by three or four doses of naltrexone 50 mg, given at 12-hour intervals pre- and post-OROS hydromorphone dosing. Plasma samples for pharmacokinetic analysis were collected pre-dose and at regular intervals up to 48 hours post-dose (72 hours for the 64-mg dose), and were assayed for hydromorphone concentration to determine peak plasma con

SUBMITTER: Sathyan G 

PROVIDER: S-EPMC1808051 | biostudies-literature | 2007 Feb

REPOSITORIES: biostudies-literature