HUMAN BIOEQUIVALENCE STUDY OF A NEW NIFEDIPINE CONTAINING RETARD FILMTABLET AFTER SINGLE AND REPEATED ADMINISTRATION

A clinical pharmacokinetic bioequivalence study with two retard filmta blet preparations, both containing 20 mg of nifedipine (CAS 219829-25- 4) was carried out. The investigated test preparation was Cordaflex(R) 20 mg retard filmtablet. The pharmacokinetic parameters were determin ed after single and repeated administration in 15 and 16 healthy male volunteers, respectively, in open, randomised studies of cross-over de sign. Plasma levels of nifedipine were determined by HPLC with electro chemical detection using a robotic sample preparation technique. Stati stical comparison of the pharmacokinetic parameters (AUC(0-infinity), AUC(ss,tau) t(max), C-max, C-ss,C-min, C-ss,C-av, MRT, etc.) calculate d from plasma concentration-time curves by ANOVA(log) confidence inter val, Schuirman's, Westlake's, Anderson's and Wilcoxon's tests, further more the comparison of the clinical results did not show any significa nt difference between the two preparations. It is concluded that the t wo preparations are bioequivalent after repeated administration.