阿莫达非尼片在健康受试者体内的药代动力学研究
发布时间：2018-07-16 17:32
【摘要】：目的研究单剂量口服阿莫达非尼片在中国健康受试者体内的药代动力学和安全性。方法用单中心、随机、开放、三剂量、三周期自身交叉的试验设计,筛选12例健康受试者并随机分组,分别接受单剂量空腹口服阿莫达非尼片100,200,400 mg。用LC-MS/MS法测定血浆中药物浓度,药代动力学参数用DAS 2.1.1软件。结果阿莫达非尼片100,200,400 mg剂量组的主要药代动力学参数如下:t1/2分别为(11.96±1.37),(12.66±1.56),(13.13±1.05)h,tmax分别为(2.41±1.43),(2.50±1.28),(3.00±1.37)h,Cmax分别为(3117±715.80),(5952±1183),(11522±2821)μg·L~(-1)。AUC0-t分别为(535.49±126.21)×10~2,(1081.53±241.91)×10~2,(2268.71±564.30)×10~2h·μg·L~(-1),AUC0-∞分别为(553.66±124.27)×10~2,(1105.26±250.90)×102,(2293.59±565.52)×10~2h·μg·L~(-1)。结论口服阿莫达非尼100~400 mg在人体内的药代动力学过程符合线性药代动力学特征。12例受试者服药后较安全。
[Abstract]:Objective to study the pharmacokinetics and safety of amodafinil tablets in Chinese healthy volunteers. Methods 12 healthy subjects were selected and randomly divided into a single-center, randomized, three-dose, three-cycle self-crossover design, and received a single dose of 100200400 mg of amodafinil tablets on an empty stomach. The plasma drug concentration was determined by LC-MS / MS method. The pharmacokinetic parameters were measured by DAS 2.1.1 software. 缁撴灉闃胯帿杈鹃潪灏肩墖100,200,400 mg鍓傞噺缁勭殑涓昏鑽唬鍔ㄥ姏瀛﹀弬鏁板涓，
本文编号：2127111
[Abstract]:Objective to study the pharmacokinetics and safety of amodafinil tablets in Chinese healthy volunteers. Methods 12 healthy subjects were selected and randomly divided into a single-center, randomized, three-dose, three-cycle self-crossover design, and received a single dose of 100200400 mg of amodafinil tablets on an empty stomach. The plasma drug concentration was determined by LC-MS / MS method. The pharmacokinetic parameters were measured by DAS 2.1.1 software. 缁撴灉闃胯帿杈鹃潪灏肩墖100,200,400 mg鍓傞噺缁勭殑涓昏鑽唬鍔ㄥ姏瀛﹀弬鏁板涓，
本文编号：2127111
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