Bioequivalence of lovastatin capsules in healthy volunteers

Objective: To evaluate the bioequivalence of two different lovastatin capsules in healthy volunteers.Methods:The whole blood concentrations of lovastatin in 20 male healthy volunteers taking orally tested and reference preparations after a single dose were determined by LC/MS/MS.The pharmacokinetic parameters were calculated by DAS2.1 software.Results:The main pharmacokinetic parameters of two lovastatin capsules were as follows:t1/2 were(4.67±2.34) and(5.30±2.62) h;tmax were(1.90±0.50) and(2.13±0.39) h;Cmax were(8.37±0.84) and(8.29±1.00) ng·mL-1;AUC0-t were(32.25±6.49)and(32.71±7.59) ng·h·mL-1;AUC0-∞ were(33.62±6.94) and(34.71±8.62) ng·h·mL-1.The relative bioavailability of test preparation was(99.60±8.30)%.Conclusion:The tested preparation was bioequivalent to the reference preparation.