Pharmacokinetic investigation of dose proportionality with a 24-hour controlled-release formulation of hydromorphone 英文参考文献.docVIP

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Pharmacokinetic investigation of dose proportionality with a 24-hour controlled-release formulation of hydromorphone 英文参考文献.doc

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Pharmacokinetic investigation of dose proportionality with a 24-hour controlled-release formulation of hydromorphone 英文参考文献

BMC Clinical Pharmacology BioMedCentral 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-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 concentration (Cmax), time at which peak plasma concentration was observed (Tmax ), terminal half-life (t1/2), and area under the concentration-time curve for zero to time t (AUC0-t) and zero to infinity (AUC ). An analysis of variance (ANO