Фарматека №4 (56) / 2002
Исследование биоэквивалентности лекарственных форм симвастатина «Симвор» и «Зокор»
1 января 2002
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.
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.
