兰索拉唑肠溶微丸胶囊人体生物等效性研究

目的:研究兰索拉唑肠溶微丸胶囊与兰索拉唑肠溶胶囊的人体生物等效性.方法:20名男性健康志愿者随机交叉单剂量口服兰索拉唑肠溶微丸胶囊(受试制剂)或兰索拉唑肠溶胶囊(参比制剂)30mg后,采用HPLC法测定血药浓度,用DAS软件计算药动学参数,并评价其生物等效性.结果:单剂量口服受试制剂兰索拉唑肠溶微丸胶囊和参比制剂兰索拉唑肠溶胶囊的主要药动学参数分别为:t1/2(1.93±0.58)、(2.21±0.84)h;tmax(1.7±0.4)、(1.7±0.4)h;Cmax(1 067.49±321.71)、(1 034.72±291.14)ng·ml-1;AUC0~12(3 655.16±1 635.82)、(3 571.70±1 434.56)ng·h·ml-1;AUC0~∞(3783.13±1 691.29)、(3 735.80±1 541.56)ng·h·ml-1.受试制剂的相对生物利用度为(106.72±13.53)%.结论:2制剂具有生物等效性.

Bioequivalence of Lansoprazole Enteric coated Pellets Capsules in Healthy Volunteers

Objective:To study the bioequivalence of lansoprazole enteric-coated pellets capsules and lansoprazole enteric-coated capsules.Method:A randomized crossover design was performed in 20 male healthy volunteers.During the two study periods,a single oral dose（30 mg）of lansoprazole enteric-coated pellets capsules（test formulation）or lansoprazole enteric-coated capsules（reference formulation）were administered to each volunteer.Plasma concentrations of lansoprazole were measured by HPLC.The pharmacokinetic parameters were calculated by DAS software and the bioequivalence was evaluated.Result:After a single oral dose of 30 mg test formulation or reference formulation,the main pharmacokinetic parameters were as follows;t_1/2of（1.93±0.58）and（2.21±0.84）h, t_max（1.7±0.4）and（1.7±0.4）h,C_maxof（1067.49±321.71）ng · ml^-1and（1 034.72±291.14）ng · ml^-1,AUC_0-12of （3 655.16±1 635.82）and（3 571.70±1 434.56）ng · h · ml^-1,AUC_0-∞of（3 783.13±1 691.29）and（3 735.80±1541.56）ng·h · ml^-1.The relative bioavailability of the test formulation was（106.72±13.53）%.Conclusion:The two formulations are bioequivalent.