2010•The Chinese Journal of Clinical PharmacologyRequires access
Bioequivalence of two kinds of domestic simvastatin capsules in healthy volunteers
Dan Liu
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Abstract
Objective To study the bioequivalence of two kinds of domestic simvastatin capsules in healthy volunteers.Methods A single oral dose of 40 mg simvastatin was given to 20 healthy volunteers in an open randomized crossover design;The concentrations of simvastatin in plasma were determined by HPLC-MS/MS method.The pharmacokinetic parameters were calculated by DAS 2.1 software.Results The main pharmacokinetic parameters of two preparations were as follows:tmax were(1.7±0.6) and(1.8±0.7) h;Cmax were(12.23±4.62) and(12.73±4.31) ng·mL-1;t1/2 were(4.2±1.6) and(4.1 ±1.4) h;AUC0-t were(42.27±27.61) and(41.81±27.75) ng·h·mL-1;AUC0-∞ were(43.99±28.60) and(43.32±28.47)ng·h·mL-1.The relative bioavailability of simvastatin was(101.8±15.8)%.Conclusion The results of demonstrated that the two preparations of simvastatin were bioequivalent.