【摘要】：目的研究單劑量口服阿莫達(dá)非尼片在中國健康受試者體內(nèi)的藥代動力學(xué)和安全性。方法用單中心、隨機、開放、三劑量、三周期自身交叉的試驗設(shè)計,篩選12例健康受試者并隨機分組,分別接受單劑量空腹口服阿莫達(dá)非尼片100,200,400 mg。用LC-MS/MS法測定血漿中藥物濃度,藥代動力學(xué)參數(shù)用DAS 2.1.1軟件。結(jié)果阿莫達(dá)非尼片100,200,400 mg劑量組的主要藥代動力學(xué)參數(shù)如下:t1/2分別為(11.96±1.37),(12.66±1.56),(13.13±1.05)h,tmax分別為(2.41±1.43),(2.50±1.28),(3.00±1.37)h,Cmax分別為(3117±715.80),(5952±1183),(11522±2821)μg·L~(-1)。AUC0-t分別為(535.49±126.21)×10~2,(1081.53±241.91)×10~2,(2268.71±564.30)×10~2h·μg·L~(-1),AUC0-∞分別為(553.66±124.27)×10~2,(1105.26±250.90)×102,(2293.59±565.52)×10~2h·μg·L~(-1)。結(jié)論口服阿莫達(dá)非尼100~400 mg在人體內(nèi)的藥代動力學(xué)過程符合線性藥代動力學(xué)特征。12例受試者服藥后較安全。
[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. 緇撴灉闃胯帿杈鵑潪灝肩墖100,200,400 mg鍓傞噺緇勭殑涓昏鑽唬鍔ㄥ姏瀛﹀弬鏁板涓，

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