Klebovich I, Drabant S, Horvai G, Nemes K B, Grézal G, Horváth V, Hrabéczy-Páll A, Kocsi E, Cseh A, Balogh J, Farsang C
Department of Pharmacokinetics, EGIS Pharmaceuticals Ltd., Budapest, Hungary.
Arzneimittelforschung. 1997 May;47(5):598-603.
A clinical pharmacokinetic bioequivalence study with two retard filmtablet preparations, both containing 20 mg of nifedipine (CAS 219829-25-4) was carried out. The investigated test preparation was Cordaflex 20 mg retard filmtablet. The pharmacokinetic parameters were determined after single and repeated administration in 15 and 16 healthy male volunteers, respectively, in open, randomised studies of cross-over design. Plasma levels of nifedipine were determined by HPLC with electrochemical detection using a robotic sample preparation technique. Statistical comparison of the pharmacokinetic parameters (AUC0-infinity, AUCss, tau tmax, Cmax, Css,min, Css,av, MRT, etc.) calculated from plasma concentration-time curves by ANOVAlog, confidence interval, Schuirman's, Westlake's, Anderson's and Wilcoxon's tests, furthermore the comparison of the clinical results did not show any significant difference between the two preparations. It is concluded that the two preparations are bioequivalent after repeated administration.
开展了一项针对两种缓释薄膜包衣片制剂的临床药代动力学生物等效性研究，这两种制剂均含有20毫克硝苯地平（CAS 219829-25-4）。所研究的试验制剂为Cordaflex 20毫克缓释薄膜包衣片。在开放、随机交叉设计研究中，分别对15名和16名健康男性志愿者进行单次和重复给药后，测定了药代动力学参数。采用机器人样品制备技术，通过高效液相色谱电化学检测法测定血浆中硝苯地平的水平。通过方差分析对数、置信区间、舒尔曼检验、韦斯特莱克检验、安德森检验和威尔科克森检验，对根据血浆浓度-时间曲线计算出的药代动力学参数（AUC0至无穷大、AUC稳态、达峰时间、Cmax、Css最低值、Css平均值、平均滞留时间等）进行统计比较，此外，临床结果比较显示两种制剂之间没有任何显著差异。得出的结论是，两种制剂在重复给药后生物等效。
