[Comparative pharmacokinetics of 800 mg of acyclovir-containing Telviran and Zovirax tablets in healthy volunteers]. / Telviran és Zovirax 800 mg acyclovir hatóanyagtartalmú tabletták összehasonlító farmakokinetikája egészséges önkénteseken.

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.

[Comparative human pharmacokinetic studies of 20 mg nifedipine-containing Cordaflex and Adalat film coated retared tablets]. / Cordaflex és Adalat 20 mg filmtabletták összehasonlító humán farmakokinetikája egyszeri és ismételt dozírozás után.

Comparative pharmacokinetic studies have been carried out with two 20 mg nifedipine active substance-containing retard film coated tablets, Cordaflex produced by EGIS Pharmaceuticals Co., Ltd. and Adalat of Bayer AG. The pharmacokinetic parameters and the relative bioavailability were determined in 15 and 16 healthy male volunteers, respectively after single and repeated administration in open, randomized cross over study. The plasma concentration of nifedipine was determined by HPLC-ED method, using laboratory robot for automated sample preparation. On the basis of graphical and statistical comparison of the pharmacokinetic parameters (AUC0-infinity, AUCss,0-tau, tmax, Cmax, Css,min, Css,av, MRT, etc.) calculated from the time-plasma concentration curve, moreover on the basis of clinical results, there was no significant difference between the two preparations. In conclusion, the relative bioavailability of Cordaflex and Adalat 20 mg retard tablets did not show significant difference after single and repeated administration.