Differential effects of food on the bioavailability of controlled-release oxycodone tablets and immediate-release oxycodone solution.
The effects of a high-fat meal on the bioavailability of oxycodone hydrochloride, administered as a recently developed 40 mg controlled-release (CR) tablet or a 20 mg immediate-release (IR) solution, were evaluated in a randomized crossover study in 22 normal male and female subjects. Serial blood samples were collected for 36 h after dosing and analyzed for oxycodone by a validated method using gas chromatography/mass spectrometry. There was no significant food effect with CR oxycodone as judged by 90% confidence interval (CI) analysis of AUC0-infinity and Cmax values under fed and fasted conditions. For the IR solution, both oxycodone bioavailability and peak plasma oxycodone concentration were significantly altered by consumption of the high-fat meal, with the mean value for AUC0-infinity increasing to 120% (CI = 109-132%) and the mean value for Cmax decreasing to 82% (CI = 47-91%) of values observed in the fasted condition. Adverse events reported for both formulations were mostly mild to moderate in severity and typical of those observed with opioids.
Department of Pharmacokinetics and Drug Metabolism, Purdue Pharma L.P., Yonkers, NY 10701, USA.
D P
DP
Benziger
R F
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Kaiko
J B
JB
Miotto
R D
RD
Fitzmartin
R F
RF
Reder
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Chasin
D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D001682:Biological Availability; D003692:Delayed-Action Preparations; D004041:Dietary Fats / Q000494:pharmacology*; D005260:Female; D018565:Food-Drug Interactions; D006207:Half-Life; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D010098:Oxycodone / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*
D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D004041:Dietary Fats; D010098:Oxycodone