简短报告：碾碎的埃替拉韦组合片剂在有或无肠内营养情况下的药代动力学
Brief Report: Pharmacokinetics of Crushed Elvitegravir Combination Tablet Given With or Without Enteral Nutrition.
作者信息
Jongbloed-de Hoon Mieke, Colbers Angela, Velthoven-Graafland Kirsten, Duisenberg-van Essenberg Marjolijn, Kruijssen Martine, Abbink Evertine, van Crevel Reinout, Burger David
机构信息
*Department of Pharmacy, Radboud University Medical Center, Nijmegen, the Netherlands; †Department of Pharmacy, Elisabeth-TweeSteden Ziekenhuis, Tilburg, the Netherlands; ‡Clinical Research Centre Nijmegen, Radboud University Medical Center, Nijmegen, the Netherlands; and §Department of Internal Medicine, Radboud University Medical Center, Nijmegen, the Netherlands.
出版信息
J Acquir Immune Defic Syndr. 2017 Apr 15;74(5):571-574. doi: 10.1097/QAI.0000000000001296.
We investigated whether a fixed-dose combination tablet of elvitegravir, cobicistat, emtricitabine, and tenofovirDF (Stribild) can be crushed and combined with enteral nutrition without influencing pharmacokinetics. This was an open-label, 3-period, single-dose, randomized, crossover trial in 24 healthy volunteers. Subjects received Stribild whole tablet with breakfast (reference), crushed/suspended Stribild + breakfast, crushed/suspended Stribild + enteral nutrition. Crushed/suspended Stribild + enteral nutrition was bioequivalent (90% confidence interval between 80% and 125%) with a whole Stribild tablet. Crushed/suspended Stribild + breakfast showed bioequivalence for the area under the curve (AUC0-32), but not for maximum concentration (Cmax) (considered not clinically relevant). Patients with swallowing difficulties or an enteral feeding tube can use crushed and suspended Stribild tablets.
我们研究了埃替格韦、考比司他、恩曲他滨和替诺福韦酯固定剂量复方片剂（绥美凯）是否可以碾碎并与肠内营养制剂混合而不影响其药代动力学。这是一项在24名健康志愿者中进行的开放标签、3期、单剂量、随机交叉试验。受试者分别接受与早餐一起服用的绥美凯整片（对照）、碾碎/混悬的绥美凯+早餐、碾碎/混悬的绥美凯+肠内营养制剂。碾碎/混悬的绥美凯+肠内营养制剂与绥美凯整片具有生物等效性（90%置信区间在80%至125%之间）。碾碎/混悬的绥美凯+早餐在曲线下面积（AUC0-32）方面显示出生物等效性，但在最大浓度（Cmax）方面未显示出生物等效性（认为无临床相关性）。有吞咽困难或使用肠内喂养管的患者可以使用碾碎并混悬的绥美凯片剂。
Zotero 插件