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pharmacokinetic investigation of dose proportionality with a 24-hour controlled-release formulation of hydromorphone药代动力学研究的剂量比例hydromorphone 24小时缓释制剂.pdf

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pharmacokinetic investigation of dose proportionality with a 24-hour controlled-release formulation of hydromorphone药代动力学研究的剂量比例hydromorphone 24小时缓释制剂

BMC Clinical Pharmacology BioMed Central Research article Open Access Pharmacokinetic investigation of dose proportionality with a 24-hour controlled-release formulation of hydromorphone Gayatri Sathyan*, Emily Xu, John Thipphawong and Suneel K Gupta Address: ALZA Corporation, Mountain View, CA, USA Email: Gayatri Sathyan* - gsathyan@; Emily Xu - nxu@; John Thipphawong - jthippha@; Suneel K Gupta - sgupta7@ * Corresponding author Published: 2 February 2007 Received: 5 May 2006 Accepted: 2 February 2007 BMC Clinical Pharmacology 2007, 7:3 doi:10.1186/1472-6904-7-3 This article is available from: /1472-6904/7/3 © 2007 Sathyan et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 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-ORO