匹伐他汀钙片在健康人体内的生物等效性研究

Bioequivalence Study of Pitvastatin Calcium Tablet in Healthy Volunteers

目的:评价两种匹伐他汀钙片在中国健康受试者体内的生物等效性。方法:24名健康受试者随机分为两组,采用双周期交叉单剂量口服匹伐他汀钙片受试制剂(国产)或参比制剂(进口)2 mg后,用液-质联用(LC-MS/MS)法测定匹伐他汀的血药浓度,并计算其药动学参数,比较二者的人体生物等效性。结果:口服受试制剂与参比制剂血浆中匹伐他汀药动学参数分别为:t1/2(13.06±7.20)、(12.89±9.49)h,cmax(49.90±22.93)、(48.18±19.70)μg/L,tmax(0.64±0.34)、(0.77±0.25)h,AUC0-48 h(118.16±54.60)、(118.08±44.50)μg·h/L。受试制剂的相对生物利用度为(99.86±24.34)%。结论:两种匹伐他汀钙片在中国健康受试者体内具有生物等效性。

OBJECTIVE： To evaluate the bioequivalence of 2 kinds of Pitvastatin calcium tablets in Chinese healthy volunteers. METHODS： 24 healthy volunteers were randomized into 2 groups. In double-cycle self-cross study, the patients were given single oral dose of Pitvastatin calcium test preparation （domestic） or reference preparation （imported） 2 mg, and the plasma concentration of pitvastatin was determined by LC-MS/MS. The main pharmacokinetic parameters were calculated, and the bioequivalence of two preparations were compared. RESULTS： The main pharmacokinetic parameters of test preparation vs. reference preparation were as follows： t1/2 （13.06 ± 7.20） h vs. （12.89 ± 9.49） h; cmax （49.90 ± 22.93）μg/L vs.（48.18 ± 19.70）μg/L;tmax （0.64 ± 0.34） h vs.（0.77 ± 0,25） h;AUC0-48h ： （118.16±54.60） μg·h/L vs.（118.08 ± 44.50） μg·h/L, The relative bioavailability of test reference was （99.86 ±24.34） %. CONCLUSIONS： The results demonstrate that the two preparations are bioequivalent.