Herein, we report a food-effect study of vonoprazan, an oral potassium-competitive acid blocker. In a phase 1, randomized, open-label, crossover study, healthy subjects received a single 20-mg dose of vonoprazan either following an overnight fast or 30 minutes after a high-fat breakfast. Plasma vonoprazan levels were determined at 0 hour and at 17 subsequent assessment points up to 48 hours after dosing. After a 5-day washout, subjects received a second 20-mg vonoprazan dose in the alternative fed/fasted state (identical process repeated). Twenty-four subjects completed the study. Vonoprazan exposure was not meaningfully affected by food. Geometric mean ratios for maximum concentration, area under the concentration-time curve from time 0 to 24 hours, and area under the plasma concentration–time curve extrapolated to infinity obtained under fed and fasting conditions were 1.05 (90% confidence interval, 0.98-1.12), 1.13 (1.09-1.18), and 1.15 (1.11-1.19), respectively. Four subjects experienced 6 adverse events that were all mild and considered unrelated to the study drug. Vonoprazan can be administered without regard to food intake.

中文翻译：

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食物对钾竞争性酸阻滞剂沃诺拉赞药代动力学的影响

在此，我们报告了一种口服钾竞争性酸阻滞剂 vonoprazan 的食物效应研究。在一项 1 期、随机、开放标签、交叉研究中，健康受试者在隔夜禁食后或在高脂早餐后 30 分钟接受单次 20 毫克剂量的沃诺拉赞。在给药后 0 小时和 17 个后续评估点测定血浆 vonoprazan 水平，直至给药后 48 小时。5 天清除后，受试者在交替进食/禁食状态下接受第二次 20 mg vonoprazan 剂量（重复相同过程）。24 名受试者完成了研究。沃诺拉赞的暴露不受食物的显着影响。最大浓度的几何平均比率，从时间 0 到 24 小时的浓度-时间曲线下面积，在进食和禁食条件下外推至无穷大的血浆浓度-时间曲线下面积和面积分别为 1.05（90% 置信区间，0.98-1.12）、1.13（1.09-1.18）和 1.15（1.11-1.19）。四名受试者经历了 6 次不良事件，这些不良事件都是轻微的，被认为与研究药物无关。沃诺拉赞可以在不考虑食物摄入的情况下给药。