Food interaction pharmacokinetic study of cordaflex 20 mg retard filmtablet in healthy volunteers.
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 [Horvai et al. 1994] with robotic sample processing [Horváth et al. 1995, 1996]. The pharmacokinetic parameters (AUC0-infinity, AUC0-t, Cmax, MRT) were analyzed by calculating 90% confidence interval for logarithmic transformed test/reference ratio values, and Schuirmann's statistical tests, the tmax 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 [Kleinbloesem et al. 1993, Schall et al. 1994], food ingestion increased the relative bioavailability and maximum plasma concentration (Cmax). Considering the average of the parameter values and also the respective statistical tests, it was also apparent that the time to maximum plasma concentration (tmax), the mean residence time (MRT), and the half-value duration (HVD) all decreased significantly upon the effect of food ingestion.
Balogh Nemes
K
K
Department of Pharmacokinetics, EGIS Pharmaceuticals Ltd., Budapest, Hungary.
Horváth
V
V
Grézal
G
G
Horvai
G
G
Hrabéczy-Páll
A
A
Kocsi
E
E
Drabant
S
S
Csörgö
M
M
Renczes
G
G
Klebovich
I
I
D000284:Administration, Oral; D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D002121:Calcium Channel Blockers / Q000097:blood / Q000493:pharmacokinetics*; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D018565:Food-Drug Interactions; D006801:Humans; D008297:Male; D009543:Nifedipine / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*
D002121:Calcium Channel Blockers; D003692:Delayed-Action Preparations; D009543:Nifedipine