FOOD INTERACTION PHARMACOKINETIC STUDY OF CORDAFLEX-20MG RETARD FILM TABLET IN HEALTHY-VOLUNTEERS

The aim of the present study was to investigate the effect of food con sumption 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 intera ction pharmacokinetic study of Cordaflex 20 mg retard filmtablet was c arried out in 12 healthy male volunteers treated with a single dose of the preparation both after fasting and after food ingestion, in a cro ssover design allowing 1 week of wash-out period between the 2 treatme nts. Nifedipine concentration of plasma samples were determined by an isocratic HPLC-ED method [Horvai et al. 1994] with robotic sample proc essing [Horvath et al. 1995, 1996]. The pharmacokinetic parameters (AU C(0-infinity), AUC(0-t), C-max, MRT) were analyzed by calculating 90% confidence interval for logarithmic transformed test/reference ratio v alues, and Schuirmann's statistical tests, the t(max) and HVD values w ere analyzed by Wilcoxon's nonparametric statistical test. The above s tatistical tests of the present food interaction study indicated signi ficant differences for each one of the respective pharmacokinetic para meter pairs calculated for treatments after fasting and after food ing estion. On the basis of the above findings and also by comparing the m ean pharmacokinetic curves, it was evident, that, in agreement with th e data of literature [Kleinbloesem et al. 1993, Schall et al. 1994], f ood ingestion increased the relative bioavailability and maximum plasm a concentration (C-max). Considering the average of the parameter valu es and also the respective statistical tests, it was also apparent tha t the time to maximum plasma concentration (t(max)), the mean residenc e time (MRT), and the half-value duration (HVD) all decreased signific antly upon the effect of food ingestion.