RELATIVE BIOAVAILITY OF SIMVASTAIN TABLET IN HEALTHY VOULUNTEERS

A single oral dose of 40mg domestic and imported simvatatin was given to 8 healthy volunteers in a randomized crossover study, simvatatin's active metabolite concentration in plasma were determined by GC/MS method . The pharmacokinetics and bioavailability were studied . The results showed that the plasma concentration_time curves of the two products were all fitted to one-compartment model. Tpeak of domestics and imported tablets were 2.71±0.19 h and 2.69±0.20 h, AUC0-∞ were 19.016±2.255 μg·h· L-1 and 20.444±2.830 μg·h·L-1, Cmax were 1.82±0.23 μg· L-1 and 1.93±0.31 μg· L-1,the relative bioavailability of domestics to imported tablets was 94.9±6.0%. There were no statistically singnificant difference between the two parameters(P0.05). The results demonstrated that two preparations were bioquivalent.