Food interaction pharmacokinetic study of Cordaflex 20 mg retard filmtablet in healthy volunteers

K. Balogh Nemes, V. Horváth, G. Grézal, G. Horvai, A. Hrabéczy-Páll, E. Kocsi, S. Drabant, M. Csörgö, G. Renczes, I. Klebovich

Research output: Article

5 Citations (Scopus)

Abstract

The aim of the present study was to investigate the effect of food consumption on the pharmacokinetics of Cordaflex 20 mg retard filmtablet in healthy volunteers through measuring nifedipine plasma levels by an HPLC-ED method both after fasting and food ingestion. The food interaction pharmacokinetic study of Cordaflex 20 mg retard filmtablet was carried out in 12 healthy male volunteers treated with a single dose of the preparation both after fasting and after food ingestion, in a crossover design allowing 1 week of wash-out period between the 2 treatments. Nifedipine concentration of plasma samples were determined by an isocratic HPLC-ED method with robotic sample processing. The pharmacokinetic parameters (AUC(0-∞), AUC(0-t), C(max), MRT) were analyzed by calculating 90% confidence interval for logarithmic transformed test/reference ratio values, and Schuirmann's statistical tests, the t(max) and HVD values were analyzed by Wilcoxon's nonparametric statistical test. The above statistical tests of the present food interaction study indicated significant differences for each one of the respective pharmacokinetic parameter pairs calculated for treatments after fasting and after food ingestion. On the basis of the above findings and also by comparing the mean pharmacokinetic curves, it was evident, that, in agreement with the data of literature, food ingestion increased the relative bioavailability and maximum plasma concentration (C(max)). Considering the average of the parameter values and also the respective statistical tests, it was also apparent that the time to maximum plasma concentration (t(max)), the mean residence time (MRT), and the half-value duration (HVD) all decreased significantly upon the effect of food ingestion.

Original languageEnglish
Pages (from-to)263-269
Number of pages7
JournalInternational Journal of Clinical Pharmacology and Therapeutics
Volume36
Issue number5
Publication statusPublished - máj. 1998

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Food-Drug Interactions
Pharmacokinetics
Healthy Volunteers
Eating
Food
Statistical tests
Fasting
Nifedipine
Plasmas
Area Under Curve
High Pressure Liquid Chromatography
Robotics
Cross-Over Studies
Biological Availability
Reference Values
Confidence Intervals
Therapeutics

ASJC Scopus subject areas

  • Toxicology
  • Pharmacology (medical)

Cite this

Food interaction pharmacokinetic study of Cordaflex 20 mg retard filmtablet in healthy volunteers. / Balogh Nemes, K.; Horváth, V.; Grézal, G.; Horvai, G.; Hrabéczy-Páll, A.; Kocsi, E.; Drabant, S.; Csörgö, M.; Renczes, G.; Klebovich, I.

In: International Journal of Clinical Pharmacology and Therapeutics, Vol. 36, No. 5, 05.1998, p. 263-269.

Research output: Article

Balogh Nemes, K, Horváth, V, Grézal, G, Horvai, G, Hrabéczy-Páll, A, Kocsi, E, Drabant, S, Csörgö, M, Renczes, G & Klebovich, I 1998, 'Food interaction pharmacokinetic study of Cordaflex 20 mg retard filmtablet in healthy volunteers', International Journal of Clinical Pharmacology and Therapeutics, vol. 36, no. 5, pp. 263-269.
Balogh Nemes, K. ; Horváth, V. ; Grézal, G. ; Horvai, G. ; Hrabéczy-Páll, A. ; Kocsi, E. ; Drabant, S. ; Csörgö, M. ; Renczes, G. ; Klebovich, I. / Food interaction pharmacokinetic study of Cordaflex 20 mg retard filmtablet in healthy volunteers. In: International Journal of Clinical Pharmacology and Therapeutics. 1998 ; Vol. 36, No. 5. pp. 263-269.
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