盐酸吡格列酮口腔崩解片在人体内的生物等效性

Bioequivalence of Pioglitazone orally disintegrating tablets in healthy volunteers

目的评价盐酸吡格列酮口腔崩解片的生物等效性。方法18名受试者随机交叉单剂量口服盐酸吡格列酮口腔崩解片与市售盐酸吡格列酮片,用HPLC测定其血浆中的浓度。结果受试者服用试验制剂与参比制剂后的Tmax分别为2.08±0.88、2.31±1.02 h,Cmax分别为1.173±0.384、1.262±0.437μg.ml-1,AUC0-24分别为9.816±3.040、10.513±3.288μg.h.ml-1,AUC0-∞分别为11.032±3.745、11.509±3.486μg.h.ml-1。结论试验制剂与参比制剂生物等效。

OBJECTIVE To study the bioequivalence of Pioglitazone orally disintegrating tablets in healthy volunteers. METHODS 18 healthy male volunteers were given a single oral dose of 10 mg Pioglitazone orally disintegrating tablets or reference Pioglitazone in a randomized cross - over study, plasma concentration of Pioglitazone was determined by HPLC. RESULTS The main pharmacokinetics of Pioglitazone in test and reference were listed as follows： Tmax were 2.08 ±0.88 h and 2.31 ±1.02 h, Cmax were 1. 173 ±0. 384 μg·ml^-1 and 1. 262 ±0. 437 μg·ml^-1, A UCo_24 were 9. 816 ± 3. 040 μg·h·ml^-1 and 10.513 ±3. 288μg·h·ml^-1, A UCo-∞were 11. 032 ± 3. 745 μg·h·ml^-1 and 11. 509 ±3. 486 μg·h·ml^-1, respectively. CONCLUSIONS The results of statistics analysis show that two preparations were bioequivalent.