The comparative pharmacokinetics of physical manipulation by crushing of Xtampza

To further characterize the pharmacokinetics of Xtampza ER. This 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 crushe...

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Veröffentlicht in:Pain management (London) 2017-11, Vol.7 (6), p.461-472
Hauptverfasser: Brennan, Michael J, Kopecky, Ernest A, Marseilles, Ann, O'Connor, Melinda, Fleming, Alison B
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Sprache:eng
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Zusammenfassung:To further characterize the pharmacokinetics of Xtampza ER. This 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. Crushed 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. This 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
ISSN:1758-1869
1758-1877
DOI:10.2217/pmt-2017-0030