Cordaflex és Adalat 20 mg filmtabletták összehasonlító humán farmakokinetikája egyszeri és ismételt dozírozás után.

Translated title of the contribution: Comparative human pharmacokinetic studies of 20 mg nifedipine-containing Cordaflex and Adalat film coated retared tablets

I. Klebovich, G. Horvai, G. Grézal, N. K. Baloghné, V. Horváth, E. Kocsi, J. Balogh, A. Cseh, C. Farsang

Research output: Contribution to journalArticle

Abstract

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.

Original languageHungarian
Pages (from-to)29-39
Number of pages11
JournalActa Pharmaceutica Hungarica
Volume66
Issue number1
Publication statusPublished - Jan 1996

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Nifedipine
Tablets
Pharmacokinetics
Biological Availability
Cross-Over Studies
Healthy Volunteers
High Pressure Liquid Chromatography
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Pharmaceutical Science

Cite this

Cordaflex és Adalat 20 mg filmtabletták összehasonlító humán farmakokinetikája egyszeri és ismételt dozírozás után. / Klebovich, I.; Horvai, G.; Grézal, G.; Baloghné, N. K.; Horváth, V.; Kocsi, E.; Balogh, J.; Cseh, A.; Farsang, C.

In: Acta Pharmaceutica Hungarica, Vol. 66, No. 1, 01.1996, p. 29-39.

Research output: Contribution to journalArticle

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abstract = "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.",
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