替硝唑片在健康人体的生物等效性

Bioequivalence of tinidazole tablets in healthy volunteers

目的比较2种替硝唑片的人体相对生物利用度,并进行生物等效性评价。方法按照两制剂两周期随机交叉设计,选择20名健康志愿者单剂量口服受试制剂或参比制剂各2片,用HPLC-UV法测定其血药浓度,DAS软件处理血药浓度数据和计算参数,并进行统计学分析。结果替硝唑受试和参比制剂AUC0→60分别为(441±54)和(449±43)μg·h·mL-1,AUC0→∞分别为(487±61)和(488±49)μg·h·mL-1;Cmax分别为(19.45±3.39)和(20.28±2.85)μg.mL-1;tmax分别为(2.90±1.54)和(2.53±1.69)h,两者无明显差异。替硝唑片的相对生物利用度为(98.3±7.7)%。结论 2种制剂具有生物等效性。

Objective To study the pharmacokinetics of tinidazole tablets in healthy human plasma.Methods Twenty healthy volunteers were given the tinidazole tablets by oral administration with 2-way crossover design.The concentration of tinidazole in plasma was determined by HPLC-UV.The pharmacokinetic parameters were calculated by DAS software.Results The pharmacokinetic parameters of tinidazole of two preparations were as follows：AUC0→60were（441±54） and（449±43）μg·h·mL-1;AUC0→∞were（487±61） and（488±49）μg·h·mL-1;Cmax were（19.45±3.39） and（20.28±2.85） μg·mL-1;tmax were（2.90±1.54） and（2.53±1.69） h,respectively.The relative bioavailability of tinidazole were（98.3±7.7）%.Conclusion The two preparations are bioequivalent.