国产与进口氟康唑胶囊在健康人体的生物等效性研究

目的：研究氟康唑胶囊受试制剂（国产）和参比制剂（进口）在20例男性健康志愿者体内的药动学和相对生物利用度,并进行生物等效性评价。方法：采用双周期两制剂随机交叉试验法,单剂量口服150mg两种氟康唑胶囊,两次试验周期之间的清洗期为两周,采用HPLC法测定血浆中氟康唑浓度。结果：受试制剂和参比制剂的t1/2分别为（31.09±5.49）和（32.57±6.33）h;tmax分别为（1.05±0.63）和（1.54±1.14）h;cmax分别为（3.90±0.43）和（3.73±0.67）μg/ml;AUC0～120分别为（128.39±15.74）和（127.30±25.64）μg.h.ml-1;AUC0～∞分别为（139.02±18.12）和（138.48±29.90）μg.h.ml-1。受试制剂和参比制剂的主要药动学参数均无显著差异（P〉0.05）。受试制剂的相对生物利用度为（102.25±9.29）%。结论：受试制剂和参比制剂具有生物等效性。

Study on bioequivalence of domestic and imported fluconazole capsules in healthy volunteers

Objective： To evaluate the pharmacokinetics and relative bioavailability of domestic and imported fluconazole capsules in 20 healthy male volunteers. Methods;A single oral dose of 150 mg test（domestic） and reference（imported） flucon- azole preparations were given respectively to the volunteers according to randomized two-way crossover study design. The wash- out period was two weeks. The plasma concentration of fluconazole was determined by HPLC method. Results： The main phar- macokinetic parameters of the test and reference preparations were as follows： t;/2 （31.09±5.49） and （32.57±6.33） h; t （1.05±0.63） and （1.54;1.14） h;cmax（3. 90±0. 43） and （3.73±0.67） btg/ml;AUC0_120 （128.39±15.74） and （127.30±25.64） μg. h. ml 1;AUC0;（139.02±18.12） and （138.48±29.90）μg. h. ml l,respectively. There were no significant differences in main pharmacokinetic parameters between the test and reference preparations （P ; 0. 05 ）. The relative bioavailability of the test preparation was （102.25±9.29）;. Conclusion：The results of statistical analysis showed that the two formulations were bioequivalent.