Pooled post hoc analysis of population pharmacokinetics of


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Oxycodone with acetaminophen
Pooled post hoc analysis of population pharmacokinetics of

Ashwanikumar N, Kumar NA, Nair SA, Kumar GS.

Published Date: 11 August 2015.

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Published 11 August 2015 Volume 2015:9 Pages 4587—4597 DOI http://dx.doi.org/10.2147/DDDT.S79499.

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Ryan M Franke, Terri Morton, Krishna Devarakonda Department of Clinical Pharmacology, Mallinckrodt Pharmaceuticals, Hazelwood, MO, USA Abstract: This analysis evaluated the single-dose population pharmacokinetics (PK) of biphasic immediate-release (IR)/extended-release (ER) oxycodone (OC)/acetaminophen (APAP) 7.5/325 mg tablets administered under fasted conditions and the effects of a meal on their single-dose population PK. Dose adjustment may be necessary for large deviations from average body weight, but the small PK effects associated with race and consumption of a meal are not clinically relevant. Under fed conditions, the absorption rate constant of OC and APAP decreased significantly, although there was no effect on CL/ F and V / F. Under fasted conditions, a 10% change in body weight was accompanied by ~7.5% change in total body clearance (CL/ F ) and volume of distribution ( V / F ) of OC and APAP. A total of 151 participants were included in the analysis under fasted conditions, and 31 participants were included in the fed analysis. Considering that the recommended dose for IR/ER OC/APAP 7.5/325 mg tablets is two tablets every 12 hours, adjustments of <50% are not clinically relevant. Participants received IR/ER OC/APAP 7.5/325 mg tablets in single doses of 7.5/325 mg (one tablet), 15/650 mg (two tablets), or 30/1,300 mg (four tablets) under fasted or fed conditions. Data were pooled from four randomized, single-dose crossover trials enrolling healthy adult (18–55 years old) participants (three trials) and nondependent recreational users of prescription opioids (one trial) with a body weight of ≥59 kg. Six variables were examined: sex, race, age, weight, height, and body mass index. Single-dose population PK was analyzed using first-order conditional estimation methods. Keywords: acetaminophen, acute pain, biphasic, extended release, fixed-dose combination, immediate release, oxycodone, population pharmacokinetics. Black participants had 17.3% lower CL/ F and a 16.9% lower V / F of OC compared with white participants.

Published Date: 11 August 2015.

Editor who approved publication: Professor Wei Duan.

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Oxycodone with acetaminophen