Исследование биоэквивалентности лекарственных форм симвастатина "Симвор" и "Зокор"
Results of comparative pharmacokinetic and bioequivalence studies of Simvor (Ranbaxy, India) and Zokorв (MSD, USA) are reported. A cross-over study design with randomised allocation of 18 volunteers was selected. Each volunteer received a single dose medication consisting of four tablets of either one of two products. Each tablet contained 20 mg of simvastatine. The wash-out period between administration of products was seven days. Sampling points were 0,5; 1,0; 1,5; 2,0; 3,0; 4,0; 6,0; and 8,0 hours after administration. Plasma samples were tested for the level of simvastatine, after a single liquid extraction, by micro-column liquid chromatography with UV- detection. Intra- and interassay variability were max, tmax, AUC(0-12). Cmax and tmax for simvastatine after single administration of Simvor and Zokor, proved to be almost 100% equivalent when comparing the dates of both drugs - 14.7±3.6 ng/ml, 1.03±0.32 h for Simvor and 15.4±3.4 ng/ml, 1.42±0.35 h) for Zokor. AUC(0-12) for Simvor were not significantly greater for Zokor (42.3±5.03 ng · h/ml and 41.55±6.67 ng · h/ml respectively. The relative bioavailability was estimated to be 1.03 ± 0.08. Study results indicate that the test drug Simvor ought to be considered as bioequivalent to the reference product Zokor.