BACKGROUND AND OBJECTIVE SHP465 mixed amphetamine salts extended release is a once-daily, single-entity, mixed amphetamine salts capsule product for attention-deficit/hyperactivity disorder. The objective of this study was to evaluate amphetamine pharmacokinetics following SHP465 mixed amphetamine salts under three administration conditions. METHODS Healthy adults (n = 16) enrolled in an open-label, randomized, three-period crossover study with three single-dose 50-mg SHP465 mixed amphetamine salts treatments (fasting ≥ 10 h before administration [reference]; high-fat meal consumption 30 min before administration; sprinkling capsule contents on applesauce) separated by ≥ 7-day washouts. Blood samples for evaluating d- and l-amphetamine pharmacokinetics were collected pre-dose and up to 60 h post-dose. Assessments included maximum plasma concentration, time to maximum plasma concentration, and area under the plasma concentration-time curve from 0 to infinity. Exponentiated least-squares mean ratios with 90% confidence intervals for test treatments relative to the reference treatment were calculated, with the absence of an effect indicated by the 90% confidence intervals falling within the 80-125% range. RESULTS Least-squares mean (90% confidence interval) ratios for maximum plasma concentration and area under the plasma concentration-time curve from 0 to infinity indicated neither consuming a high-fat meal (d-amphetamine: 85.33 [80.44, 90.50] and 91.11 [86.69, 95.75], respectively; l-amphetamine: 85.22 [80.18, 90.59] and 88.74 [83.89, 93.87]) nor sprinkling the capsule contents on applesauce (d-amphetamine: 95.76 [90.28, 101.57] and 95.77 [91.13, 100.65]; l-amphetamine: 96.90 [91.16, 103.00] and 94.78 [89.60, 100.26]) altered amphetamine exposure. Consuming a high-fat meal prolonged median time to maximum plasma concentration for d- and l-amphetamine by 5.0 and 4.5 h, respectively, relative to reference treatment. CONCLUSIONS These findings demonstrate SHP465 mixed amphetamine salts capsules can be swallowed whole with or without food or the capsule contents can be sprinkled on applesauce.

中文翻译：

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食物对SHP465混合苯丙胺盐盐缓释胶囊给药后健康成年人苯丙胺生物利用度的影响。

背景和目的SHP465混合苯丙胺盐缓释剂是一种每日一次，单实体，混合苯丙胺盐胶囊剂产品，用于注意力不足/多动症。这项研究的目的是在三种给药条件下评估SHP465混合苯丙胺盐后的苯丙胺药代动力学。方法健康成人（n = 16）参加了一项开放标签，随机，三期交叉研究，研究了三种单剂量50 mg SHP465混合苯丙胺盐治疗（给药前禁食≥10小时[参考]；高脂餐）服用前30分钟食用；将胶囊内容物撒在苹果酱上），间隔≥7天。在给药前和给药后最多60小时收集用于评估d-和l-苯异丙胺药代动力学的血样。评估包括最大血浆浓度，达到最大血浆浓度的时间以及血浆浓度-时间曲线下从0到无穷大的面积。计算出相对于参考治疗，试验治疗的置信区间为90％的指数最小二乘均值比，没有90％的置信区间落在80-125％范围内的影响。结果最大血浆浓度和血浆浓度-时间曲线（从0到无穷大）下的最大血浆浓度和面积的最小二乘均值（90％置信区间）比率表明两者均未食用高脂餐（d-苯丙胺：85.33 [80.44、90.50]和91.11） [分别为[86.69、95.75]； 1-苯丙胺：85.22 [80.18、90.59]和88.74 [83.89、93.87]），也没有将胶囊内容物撒在苹果酱上（d-苯丙胺：95.76 [90.28、101.57]和95.77 [91。13，100.65]；1-苯丙胺：96.90 [91.16，103.00]和94.78 [89.60，100.26]）改变了苯丙胺的暴露量。相对于参考治疗，高脂餐使d-苯异丙醇和l-苯异丙胺最大血浆浓度的中位时间分别延长了5.0和4.5 h。结论这些发现表明，SHP465混合苯丙胺盐胶囊可以与食物一起或不与食物一起吞咽，也可以将胶囊内容物撒在苹果酱上。