左乙拉西坦片在健康人体内的生物等效性研究

Bioequivalence of Levetiracetam Tablets in Healthy Volunteers

目的:研究2种左乙拉西坦片在中国健康人体内的生物等效性。方法:20名健康男性志愿者随机交叉单剂量口服左乙拉西坦片受试制剂(国产)与参比制剂(进口)500mg后,采用高效液相色谱-紫外(HPLC-UV)法测定人血浆中左乙拉西坦的浓度,应用SPSS17.0统计软件进行统计、分析。结果:受试制剂与参比制剂中左乙拉西坦的主要药动学参数分别为:cmax(17.34±3.45)、(16.34±3.46)mg/L,tmax(0.6±0.3)、(0.6±0.3)h,AUC0-36h(123.2±15.7)、(121.5±18.4)mg·h/L,AUC0-∞(129.4±15.3)、(128.5±17.7)mg·h/L。受试制剂对参比制剂的相对生物利用度为(102.0±7.8)%。结论:2种左乙拉西坦片剂具有生物等效性。

OBJECTIVE ： To study the bioequivalence of 2 kinds of Levetiracetam tablets in Chinese healthy volunteers. METHODS： In randomized crossover study, 20 healthy male volunteers were given single oral dose of test preparation （domestic） and reference preparation （imported） of Levetiracetam tablet （500 mg）. The concentration of levetiracetam in human plasma was measured by HPLC-UV. All statistic analysis was performed by using SPSS 17.0 statistics software. RESULTS： Main pharmacokinetic parameters of test and reference preparation were as follow： C_max were （17.34 ± 3.45） mg/L and （16.34 ± 3.46） mg/L; t_max were （0.6±0.3） h and （0.6±0.3） h; AUC_0-24 were （123.2±15.7） mg·h/L and （121.5±18.4） mg·h/L; AUC_0-∞ were （129.4±15.3） mg·h/L and （ 128.5 ± 17.7） mg·h/L. The relative bioavailability of test preparation was （ 102.0 ± 7.8） %. CONCLUSIONS ： 2 kinds of Levetiracetam tablets are bioequivalent.