托吡酯片人体生物等效性研究

Bioequivalence of Topiramate Tablets in Healthy Male Volunteers

目的研究国产与进口托吡酯片口服给药后的人体生物等效性。方法采用两制剂双周期交叉试验设计,18名健康男性受试者分别单剂量口服国产或进口托吡酯片100mg,采用高效液相色谱-质谱法测定人血浆中托吡酯的浓度。结果国产片与进口片的Cmax分别为(1222±237)、(1274±180)μg/L,tmax分别为(1.5±1.0)、(1.2±0.9)h,AUC0~120分别为(40520±7524)、(40458±4731)(μg.h)/L,AUC0~∞分别为(44379±8082)、(44380±4952)(μg.h)/L,t1/2分别为(34.4±5.0)、(35.5±4.8)h;国产片的相对生物利用度为(100.8±19.2)%。结论国产与进口托吡酯片具有生物等效性。

OBJECTIVE:To study the bioequivalence of domestic and imported topiramate tablets administered orally in healthy volunteers.METHODS:In a randomized crossover study,a single oral dose of100mg domestic or imported topiramate tablets was given to18healthy male volunteers.The concentration of topiramate in plasma was determined by a validated HPLC-MS assay.RESULTS:The parameters of domestic and imported topiramate were as follows:C max (1222±237)and(1274±180)μg/L;t max (1.5±1.0)and(1.2±0.9)h;AUC 0～120 (40520±75...