塞克硝唑胶囊在健康人体内的生物等效性

Bioavailability study on secnidazole capsule in healthy volunteers

目的研究塞克硝唑胶囊与片剂的药动学特征,并评价其生物等效性。方法随机交叉试验设计,20名健康志愿者单剂量口服塞克硝唑胶囊和塞克硝唑片剂1.5 g后,在规定时间取血,用HPLC法测定血药浓度,进行数据处理,计算2种制剂的主要药动学参数,进行人体生物利用度比较。结果受试制剂和参比制剂药动学参数分别为:tmax(2.00±0.00)、(2.15±0.37)h;ρmax(38.89±4.18)(、38.77±3.20)mg.L-1;ACU0→∞(1 320.25±287.29)(、1 292.40±234.39)mg.h.L-1;ACU0→96h(1 239.05±260.99)(、1 232.12±217.63)mg.h.L-1;t1/2(22.64±3.58)、(20.70±2.83)h;药动学参数差异无统计学意义。相对生物利用度(F)101.47%。结论塞克硝唑2种制剂在健康人体内具有生物等效性。

AIM To study pharmacokinetic characteristics and evaluate the bioequivalence of two secnidazole preparations. METHODS Secnidazole plasma concentrations were determinated and assessed by HPLC after oral single dose of 1.5 g in 20 healthy Chinese volunteers with an open randomized crossover test. So relative bioavailability and bioequivalence of two secnidazole preparations were caculated and compared. RESULTS The average of pharmacokinetic parameters after oral single dose of the test drug or reference ones were as follows, respectively： tmax（2.00 ± 0.00）, （2. 15 ± 0.37）h; ρmax（38.89±4. 18）, （38.77±3.20） mg·L^-1 ; ACU0→∞ （ 1 320.25±287.29）, （ 1 292.40±234.39） mg·h·L^-1 ; ACU0→96h（1 239.05 ± 260.99）, （1 232.12 ± 217.63）mg·h· L^-1 ; t1/2（22.64 ± 3.58） ,（20.70 ± 2.83）h. There was no significant difference of pharmacokinetic parameters between two prearations. The relative bioavailability was 101.47%. CONCLUSION The two preparation are bioequivalent.