Differential effects of food on the bioavailability of controlled-release oxycodone tablets and immediate-release oxycodone solution

被引：33

作者：

Benziger, DP ^{[1
]}

Kaiko, RF ^{[1
]}

Miotto, JB ^{[1
]}

Fitzmartin, RD ^{[1
]}

Reder, RF ^{[1
]}

Chasin, M ^{[1
]}

机构：

[1] PURDUE FREDERICK CO,DEPT MED,NORWALK,CT 06850

来源：

JOURNAL OF PHARMACEUTICAL SCIENCES | 1996年 / 85卷 / 04期

关键词：

D O I：

10.1021/js950403a

中图分类号：

R914 [药物化学];

学科分类号：

100701 ;

摘要：

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 AUC(0-infinity) and C-max 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 AUC(0-infinity), increasing to 120% (CI = 109-132%) and the mean value for C-max 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.

引用

页码：407 / 410

页数：4