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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。
Objective To study the bioequivalence of ganciclovir dispersible tablets and capsules in human. Methods A double-crossover randomized controlled trial was designed. Twenty healthy subjects received single-dose oral ganciclovir capsules and dispersible tablets at a dose of 1000 mg respectively. The plasma concentrations were determined by HPLC. The pharmacokinetic parameters were calculated by DAS 2.0 software. Carry out the equivalence test. Results The main pharmacokinetic parameters of ganciclovir dispersible tablets and capsules were ρ max 0.58 ± 0.18 and 0.60 ± 0.20 mg · L -1, (4.6 ± 1.3) and (4.6 ± 0.8) h respectively, and the AUC_ (0-t) were (2.8 ± 0.8) and ) mg · h · L -1, the average relative bioavailability of ganciclovir dispersible tablets and capsules was (96 ± 28)%. Conclusions Ganciclovir dispersible tablets and capsules are bioequivalent in humans.