食物对100毫克苯妥英钠胶囊生物利用度的影响。
Effect of food on the bioavailability of 100-mg dilantin Kapseals.
作者信息
Cook J, Randinitis E, Wilder B J
机构信息
Department of Clinical Pharmacokinetics and Pharmacodynamics, Pfizer Global Research and Development, Ann Arbor, MI 48105, USA.
出版信息
Neurology. 2001 Aug 28;57(4):698-700. doi: 10.1212/wnl.57.4.698.
The authors examined the effect of food on the bioavailability of Dilantin Kapseals in a nonblinded, single 100-mg dose, randomized, crossover trial. Drug was administered after an 8-hour fast and after a high-fat meal. Differences in mean dietary state values were +6% for maximum concentrations (C(max)) and -2% for area under the curve. Associated 90% CI were within US Food and Drug Administration criteria, confirming the absence of a food effect. Thus, patients may take 100-mg Dilantin Kapseals without regard to meals.
作者在一项非盲法、单次100毫克剂量、随机、交叉试验中研究了食物对苯妥英钠胶囊生物利用度的影响。药物在禁食8小时后和高脂餐后给药。平均饮食状态值的差异为，最大浓度（C(max)）增加6%，曲线下面积减少2%。相关的90%置信区间在美国食品药品监督管理局的标准范围内，证实不存在食物效应。因此，患者服用100毫克苯妥英钠胶囊时无需考虑用餐情况。
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