罗格列酮钠片在健康人体的生物等效性研究___

摘要 目的：评价两种罗格列酮钠片在健康人体内的生物等效性。方法：20名健康男性志愿者采用双周期随机交叉设计自身对照法，单剂量口服两种罗格列酮钠片剂（受试制剂和参比制剂） 8 mg，用反相高效液相色谱-荧光法测定罗格列酮钠的血药浓度。结果：受试制剂与参比制剂的主要药动学参数： Tmax 分别为（2.00 ± 0.00）和（2.16 ± 1.27）h；Cmax 分别为（743.54 ± 173.23）和（707.68 ± 77.62）ng•mL-1；t1/2分别为（3.70 ± 0.63）和（3.46 ± 2.18）h；AUC 0～24分别为（2811.46 ± 151.23）和（2473.04 ± 75.07）ng•h•mL-1；AUC 0～∞分别为（2947.53 ± 164.77）和（2489.19 ± 99.25）ng•h•mL-1；受试制剂相对生物利用度为（105.97 ± 18.82）%。经方差分析和双单侧t检验结果显示，两种片剂具有生物等效性。结论：两种罗格列酮钠片具有生物等效性。

Abstract Objective：To evaluate the bioequivalence of two Rosiglitazone Sodium Tablets in healthy volunteers. Method：In a randomized , crossover and self-control study , 20 healthy male volunteers were orally administrated with Rosiglitazone Sodium tables 8mg. The plasma concentration of Rosiglitazone was determined by RP-HPLC with fluorimetric detection. Results：The main pharmacokinetic parameters of the test and reference preparation were as follows：Tmax （2.00 ± 0.00） and （2.16 ± 1.27）h；Cmax （743.54 ± 173.23） and （707.68 ± 77.62）ng•mL-1；t1/2 （3.70 ± 0.63） and （3.46 ± 2.18）h；AUC 0～24 （2811.46 ± 151.23） and （2473.04 ± 75.07）ng•h•mL-1； AUC 0～∞ （2947.53 ± 164.77） and （2489.19 ± 99.25）ng•h•mL-1 respectively. The relative bioavailability of Rosiglitazone Sodium tables was （105.97± 18.82）%. The relative bioavailability of Rosiglitazone Sodium tables was（105.97 ± 18.82）% 。Conclusion：The results of statistic analysis showed that the two preparations were bioequivalent.