摘要
目的：观察硫普罗宁片剂在健康人体的生物等效性特点。方法：36名健康男性志愿者随机分成两组，分别给予口服两种硫普罗宁片（单剂量400mg），测定两组受试对象全血中药物浓度，比较两组片剂的生物等效性。结果：两组硫普罗宁的主要药动力学参数无明显差异（P〉0．05），受试制剂相对于参比制剂的生物利用度为（97．1±13．8）％。结论：两种制剂生物等效。
Objective To study the pharmacokinetics profiles of tiopronin and observe the bioequivalence of two tiopronin tablets in healthy volunteers. Methods In a randomized crossover study, 36 healthy male volunteers were given a single oral dose of400mg tiopronin tablets. The whole blood concentrations of tiopronin were determined. Results The main pharmacokinetics parameters of the two groups have no difference（ P 〉 0.05 ）. The relative bioavailabihty of the tablets was （97.1 ± 13.8）%. Conlusion the two formulations were bioequivalent.
