Pharmacokinetics of rosuvastatin calcium tablets in Chinese healthy volunteers after a single oral dose administration

Objective To investigate the pharmacokinetics of single dose of rosuvastatin calcium tablets in Chinese healthy volunteers.Methods Twelve volunteers were divided into three groups by 3×3 design.The drug concentrations of plasma sample from the twelve volunteers after taking 5,10 and 20 mg rosuvastatin were determined by LC-MS.The pharmacokinetic parameters were calculated by BAPP software.Results The healthy volunteers were given single dose of rosuvastatin with 5,10 and 20 mg,respectively.The main pharmacokinetic parameters were as follows:Cmax were(6.54±2.06),(10.61±3.35)and(22.85±7.32)ng·mL-1;AUC0-72 were(77.83±25.43),(136.12±48.63)and(275.98±81.98)h·ng·mL-1;tmax were(3.7±1.2),(3.8±0.8)and(3.4±1.0)h;t1/2 were(23.26±5.54),(25.64±14.02)and(20.54±5.80)h;CL/F were(65.40±19.05),(76.96±36.47)and(76.18±33.35)L·h-1,respectively.The main pharmacokinetic parameters Cmax,AUC0-72,AUC0-∞ are directly proportion to doses.There were no singnificant difference in Ka,Ke,tmax,t1/2ka,t1/2,MRT and CL/F of three groups by analysis of variance.Conclusion The pharmacokinetics of rosuvastatin in the dosage of 5～20 mg in human body nearly fit linear dynamic feature.