Baloghné N K, Grézal G, Dalmadiné K B, Tömló J, Patai V, Nagy L, Mózsik G, Csörgó M, Szentpéteri I, Klebovich I
Klinikai Farmakológiai Osztály, Orvostudományi Fóosztály, Budapest.
Acta Pharm Hung. 1999 Jan;69(1):36-45.
The authors performed a detailed comparative clinical and pharmacokinetic study with two 800 mg acyclovir containing tablets, namely the Telviran (EGIS Pharmaceuticals Ltd.) and the Zovirax (Wellcome Foundation Ltd.). The determination of the detailed pharmacokinetic parameters and the relative bioavailability was carried out on 24 healthy male volunteers in a two way, open, randomised, cross-over design study after single dose administration. The plasma concentration of acyclovir was determined by a newly developed and validated highly sensitive (LLOQ = 10 ng/ml) HPLC-UV bioanalytical method after sample preparation with RP-18 solid phase extraction method (SPE). The individual pharmacokinetic parameters calculated from the time-plasma concentration curve (tmax, Cmax, AUC0-infinity, AUC0-16, AUC0-t, AUC0-z, AUCRest, t beta 1/2, MRT, Cmax/AUC0-infinity) were compared with statistical methods (ANOVA, ANOVAlog, Confidence interval, Schuirmann, Wilcoxon tests). On the basis of the results of the statistical evaluation and the clinical study, there was no significant difference found between the two acyclovir containing preparations. The comparative pharmacokinetic study demonstrated, that the relative bioavailability of the 800 mg Telviran and Zovirax tablets are equivalent and the two products are bioequivalent.
作者对两种含800mg阿昔洛韦的片剂进行了详细的比较临床和药代动力学研究，这两种片剂分别是特尔维兰（EGIS制药有限公司）和阿昔洛韦（威康信托基金会有限公司）。在单剂量给药后，采用双向、开放、随机、交叉设计研究，对24名健康男性志愿者进行了详细药代动力学参数和相对生物利用度的测定。用RP - 18固相萃取法（SPE）制备样品后，采用新开发并验证的高灵敏度（LLOQ = 10 ng/ml）HPLC - UV生物分析方法测定阿昔洛韦的血浆浓度。用统计方法（方差分析、对数方差分析、置信区间、舒尔曼检验、威尔科克森检验）比较从时间 - 血浆浓度曲线计算出的个体药代动力学参数（tmax、Cmax、AUC0 - ∞、AUC0 - 16、AUC0 - t、AUC0 - z、AUCRest、tβ1/2、MRT、Cmax/AUC0 - ∞）。根据统计评估结果和临床研究，两种含阿昔洛韦制剂之间未发现显著差异。比较药代动力学研究表明，800mg特尔维兰和阿昔洛韦片剂的相对生物利用度相当，两种产品生物等效。
