Bioequivalence of Simvastain Tablets in Healthy Volunteers / 中国药房

ABSTRACT

OBJECTIVE: To compare the bioequivalence between two kinds of Simvastain Tablets.METHODS: A single dose of 40mg of domestic Simvastain Tablets(test preparation) and imported Simvastain Tablets(reference preparation) was administered by randomized crossover way in 20 healthy volunteers with plasma concentrations of simvastain determined by liquid chromatography mass spectrometry. The pharmacokinetic parameters were calculated with 3p97 pharmacokinetic program and the bioavailability was evaluated.RESULTS: The concentration-time curve of two preparations fitted one compartment model.The pharmacokinetic parameters of the test preparation vs.the reference preparation were as follows Cmax(13.23?4.41) ng?mL-1 vs.(12.68?4.43) ng?mL-1;tmax(1.64?1.20) h vs.(1.54?1.28) h;AUC0～12(47.48?22.96)vs.(44.49?18.47) ng?h?mL-1;AUC0～∞(50.87?24.06) ng?h?mL-1 vs.(47.11?19.54) ng?h?mL-1.The relative bioavailability of the test simvastain tablets was(106.72?15.20)%.CONCLUSION: The results suggest that two preparations are bioequivalent.