利巴韦林片健康人体生物等效性评价

目的研究两种国产利巴韦林片在健康人体的生物等效性。方法20名健康志愿者采用双周期交叉试验,单剂量空腹口服两种利巴韦林片各300 mg,HPLC法测定其血清中利巴韦林浓度,血药浓度-时间数据经DAS2.0统计软件处理,计算主要药代动力学参数,并进行两种制剂的生物等效性评价。结果利巴韦林受试制剂与参比制剂的主要药代动力学参数分别为：Cmax0.346±0.174和0.365±0.125 mg.L^-1、Tmax1.475±0.436和1.588±0.731 h、AUC0-24 h2.649±0.762和2.560±0.743 mg.h-1.L^-1。受试制剂的相对生物利用度为111.99%±47.75%。结论统计学分析结果显示,两种制剂具有生物等效性。

Evaluation on the bioequivalence of two domestic ribavirin tablets in Chinese healthy volunteers

Aim To investigate the bioequivalence of two domestic ribavirin tablets in Chinese healthy volunteers.Method Twenty volunteers were randomly divided into two groups（test and reference）,with double cross over design.The concentration of ribavirin in serum was determined by HPLC and pharmacokinetic parameters were calculated with DAS2.0 practical pharmacokinetics program.Results The pharmacokinetic parameters of two domestic ribavirin tablets were as follows：Cmax0.346±0.174 and 0.365±0.125 mg·L-1,Tmax1.475±0.436 and 1.588±0.731 h,AUC0-24 h 2.649±0.762 and 2.560±0.743 mg·h-1·L-1.The relative bioavailibility of ribavirin tablets was 111.99%±47.75%.Conclusion The statistical analysis showed that the test and reference preparation were bioequivalent.