劳拉西泮片人体生物等效性研究

 目的评价国产劳拉西泮片与已上市的进口劳拉西泮片的人体生物等效性。方法20名男性健康志愿者随机交叉口服劳拉西泮受试制剂和参比制剂2 mg,采用液相色谱-质谱法测定血清药物浓度。结果劳拉西泮参比制剂及受试制剂的t_max分别为(2.925±1.017)和(2.825±0.832)h,c_max分别为(19.642±4.988)和(20.185±4.560)ng·mL-1,AUC_0～60分别为(357.62±70.95)和(370.21±88.29)ng·h·mL^-1,t_1/2(ke)分别为(14.268±2.790)和(14.378±3.697)h,国产劳拉西泮片相对生物利用度为(103.33±12.32)% 结论方差分析和双单侧t检验结果表明两种制剂生物等效。

Studies on the bioequivalence of lorazepam tablet in healthy volunteers

OBJECTIVE To evaluate the bioequivalence of domestic lorazepam tablet and imported lorazepam tablet in healthy volunteers. METHODS A single oral 2 mg test or reference preparations of lorazepam was given to 20 healthy volunteers in a randomized crossover study. The serum concentrations of lorazepam were determined by HPLC-MS assay. RESULTS The main pharmacokinetic parameters of the two products were as follow:t_max,(2.925±1 .017) and(2.825±0.832 )h;c_max,(19.642±4.988) and(20. 185±4.560) ng· mL^-1; AUC_0～60, (357.62±0.95) and (370.21±88.29)ng·h·mL^-1;t_1/2(ke)(14.268±2.790) and(14.378±3.697) h, respectively.The relative bioavail-ability of the test to reference tablet was (103.33±12.32)% .CONCLUSION The results of variance analysis and two one-side t test showed that the two formulations were bioequivalent.