摘要
目的:比较国产与进口非那雄胺片的人体生物等效性。方法:18例健康男性单次随机交叉口服非那雄胺10mg后,用HPLC法测定血清中各时的药物浓度,计算两者的药物动力学参数和相对生物利用度,进行生物等效性评价。结果:国产及进口非那雄胺片的主要药动学参数如下:AUC0-t分别为(1039·13±272·37)和(1008·60±244·77)μg·h·L-1,Cmax分别为(128·72±26·69)和(117·32±25·20)μg·L-1,Tmax分别为(2·69±0·39)和(2·69±0·49)h,供试制剂相对于参比制剂的人体生物利用度为(106·58±27·79)%。结论:国产与进口非那雄胺片具有生物等效性。
Objective:To evaluate the bioequivalence of finasteride tablets imported (reference) to locally manufactured (test).Methods: 18 healthy male volunteers were randomized orally to receive a single crossover dose of test or reference tablets ( 10 mg) . The serum finasteride concentrations were determined by HPLC. The pharmacokinetic profiles of test and reference tablets were compared. Results : The pharmacokinetics parameters without significant difference of test and reference granules were as follows: Cmax(128.72±26.69) vs. (117.32 ±25.20) μg·h·L^-1, Tmax(2.69 ±0.39) vs. (2.69 ±0.49) h, AUC0-1,(1 039.13 ±272.37) vs (1 008.60 ±244.77)μg·h·L^-1. The relative bioavaiiability of the test tablets was (106.58 ±27.79)%. Conclusion:The test tablets are bioequivalent to the reference tablets.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2005年第7期906-908,共3页
Chinese Journal of New Drugs