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Randomized Controlled Trial Comparative Study
The comparative pharmacokinetics of physical manipulation by crushing of Xtampza® ER compared with OxyContin®.
- Michael J Brennan, Ernest A Kopecky, Ann Marseilles, Melinda O'Connor, and Alison B Fleming.
- Chronic Pain & Recovery Program, Silver Hill Hospital, 208 Valley Road, New Canaan, CT 06840, USA.
- Pain Manag. 2017 Nov 1; 7 (6): 461-472.
AimTo further characterize the pharmacokinetics of Xtampza® ER.Subjects & MethodsThis was an open-label, randomized, active-controlled, five-treatment, five-period, naltrexone-blocked, cross-over study. Healthy subjects received five equivalent oxycodone doses: Xtampza ER (intact or crushed), OxyContin® (intact or crushed) or immediate-release (IR) oxycodone (crushed). Blood samples were collected to assess oxycodone concentrations.ResultsCrushed and intact Xtampza ER resulted in lower peak plasma concentrations compared with crushed oxycodone IR; crushed and intact Xtampza ER were bioequivalent. Crushed OxyContin exhibited a rapid increase in plasma oxycodone and was bioequivalent to crushed oxycodone IR.ConclusionThis second pharmacokinetic study demonstrated that Xtampza ER maintains its ER properties after crushing, unlike OxyContin, which failed to retain its ER properties after crushing. ANZCTR registration number: ACTRN12614000613606.
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