格列喹酮片人体药动学及生物等效性研究

目的:研究2种格列喹酮片在健康男性体内的药动学及生物等效性。方法:20名健康男性志愿者随机分为2组,分别交叉单剂量口服受试制剂或参比制剂60mg,清洗期为1wk。服药后12h内采集血样,血浆中格列喹酮浓度采用高效液相色谱法测定。结果:受试制剂和参比制剂的Cmax分别为(1·541±0·597)、(1·510±0·505)μg/ml;tmax分别为(3·000±1·051)、(2·700±0·696)h;AUC0~Tn分别为(7·237±2·446)、(6·924±2·208)(μg·h)/ml。统计分析各参数间无显著性差异(P>0·05)。受试制剂的相对生物利用度为(107·8±30·0)%。结论:2种格列喹酮片具有生物等效性。

Pharmacokinetics and Relative Bioavailability of Gliquidone Tablet in Volunteers

OBJECTIVE:To evalute the pharmacokinetics and bioequivalence between 2 gliquidone tablet in health male volunteers.METHODS:It was designed as randomized,two-way crossover study with 1 week washout interval,blood sample was collected throughout a 12h period after administration a singer oral 60mg dose of test and reference product to 20 health male volunteers,the plasma concentrations of gliquidon were assayed by HPLC.RESULTS:Cmax and tmax for the test and the reference preparation were (1.541±0.597),(1.510±0.505)μg/ml and (3.000±1.051), (2.700±0.696)h, respectively, Whereas the AUC0～Tn amounted to (7.237±2.446)and(6.924±2.208)(μg·h)/ml. The results of statistical analysis showed that there was no significant difference(P>0.05) among these pharmacokinetic parameters. The relative bioavailability of the test preparation was(107.8±30.0)%. CONCLUSION: The test and the reference preparation are bioequivalent.