Human bioequivalence study of a new nifedipine containing retard filmtablet after single and repeated administration

Imre Klebovich, Sándor Drabant, George Horvai, Katalin Balogh Nemes, Gyula Grézal, Viola Horváth, Andrea Hrabéczy-Páll, Emilia Kocsi, Anna Cseh, Julia Balogh, Csaba Farsang

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3 Citations (Scopus)

Abstract

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 or 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 (AUC(0-∞), AUC(ss,t), t(max), C(max), C(ss,min), C(ss,av), MRT, etc.) calculated from plasma concentration-time curves by ANOVA(log), 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.

Original languageEnglish
Pages (from-to)598-603
Number of pages6
JournalArzneimittel-Forschung/Drug Research
Volume47
Issue number5
Publication statusPublished - Jun 24 1997

Keywords

  • CAS 21829-25-4
  • Calcium antagonist
  • Cordaflex®, bioequivalence, clinical studies
  • Nifedipine

ASJC Scopus subject areas

  • Drug Discovery

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