【摘要】 目的:评价2种匹伐他汀钙片在人体内的生物等效性。方法:20例男性健康志愿者随机交叉单剂量口服试验制剂和参比制剂,利用LC-MS/MS法测定匹伐他汀体内血药浓度。结果:试验制剂和参比制剂的主要药动学参数如下:AUC0-t分别为(180.2±37.6)μg.h.L-1和(182.6±36.1)μg.h.L-1;AUC0-∞分别为(190.0±38.1)μg.h.L-1和(189.6±37.4)μg.h.L-1;Cmax分别为(54.3±18.2)μg.L-1和(65.1±22.4)μg.L-1;tmax分别为(0.80±0.25)h和(0.78±0.26)h;t1/2分别为(13.4±4.5)h和(12.0±2.8)h;经方差分析和双单侧t检验显示,主要药动学参数无显著差异,以AUC0-t计算匹伐他汀钙片的相对生物利用度为(100.3±19.9)%。结论:试验制剂与参比制剂具有生物等效性。更多还原

【Abstract】 OBJECTIVE To evaluate the bioequivalence of two preparations of pitavastatin calcium tablets in healthy volunteers.METHODS In a two-way cross-over study,20 healthy volunteers were randomly divided into two groups and taken a single oral dose of pitavastatin calcium tablets of test and reference preparation respectively.The concentration in plasma was determined with LC-MS/MS.RESULTS The main pharmacokinetic parameters of test and reference were as follows: AUC(0-t)(180.2±37.6)μg·h·L-1 and(182.6±36.1)μg·h·L-1;AUC(0-∞)(190.0±38.1)μg·h·L-1 and(189.6±37.4)μg·h·L-1;Cmax(54.3±18.2)μg·L-1 and(65.1±22.4)μg·L-1;tmax(0.80±0.25)h and(0.78±0.26)h;t1/2(13.4±4.5)h and(12.0±2.8)h;The relative bioavailability of pitavastatin calcium was(100.3±19.9)%.CONCLUSION The test and reference preperation of pitavastatin calcium tablets are bioequivalent.更多还原