更昔洛韦分散片和胶囊在健康人体中的生物等效性

Bioequivalence of ganciclovir dispersible tablets and capsules in Chinese healthy volunteers

目的研究更昔洛韦分散片和胶囊在人体内的生物等效性。方法采用双交叉随机自身对照试验设计,20名健康受试者分别单剂量口服更昔洛韦胶囊和分散片1000mg后,采用HPLC法测定血药浓度,DAS2.0软件计算药动学参数,并进行等效性检验。结果更昔洛韦分散片和胶囊的主要药动学参数:ρ_(max)分别为(0.58±0.18)和(0.60±0.20)mg·L^(-1),τ_(max)分别为(3.0±0.4)和(3.2±0.4)h,t_(1/2)分别为(4.6±1.3)和(4.6±0.8)h,AUC_(0-t)分别为(2.8±0.8)和(3.2±1.2)mg·h·L^(-1),更昔洛韦分散片和胶囊的平均相对生物利用度为(96±28)%。结论更昔洛韦分散片和胶囊在人体内生物等效。

AIM To evaluate the bioequivalence of ganciclovir dispersible tablets and capsules in Chinese healthy volunteers.METHODS In a randomized,crossover and self-controlled study,20 male healthy volunteers were administered with a single oral dose of test and reference preparations containing 1000 mg ganciclovir,respectively.The plasma concentrations of ganciclovir were determined by HPLC-UV.The pharmacokinetic parameters were calculated and the bioequivalence of the two preparations was evaluated by DAS software 2.0.RESULTS The main pharmacokinetic parameters of the ganciclovir dispersible tablets and capsules were as follows：ρ_（max）were（0.58±0.18）and（0.60±0.20）mg·L^-1,τmaxwere（3.0±0.4）and （3.2±0.4）h,t_（1/2）were（4.6±1.3）and（4.6±0.8）h,AUC（？）were（2.8±0.8）and（3.2±1.2）mg·h·L^-1. The relative bioavailability of ganciclovir dispersible tablets was（96±28）%.CONCLUSION Ganciclovir dispersible tablets and capsules are bioequivalent.