The Pharmacokinetics and Relative Bioavailability of Simvastatin Capsules in Healthy Volunteers
Tan L · The Chinese Journal of Clinical Pharmacology · 2000
The pharmacokinetics and relative bioavailability of simvastatin capsules were studied in 12 healthy male volunteers. A single oral dose 40mg simvastatin of reference(tablet) or test(capsules) drugs was given to each volunteer according to an open randomized crossover study. The concentrations in plasma were determined by HPLC method. The results showed that the plasma concentration-time curves of the two products were all fitted to one-compartment model. The main pharmacokinetic parameters of simvastatin were: AUC_0 - 10 25.21 ± 8.29(mg· h·L _-1) and 25.99 ± 7.85 (mg·h·L_-1), T_max l.92 ± 0.36 h and l.79 ± 0.45 h, C_max 7.96 ± 2.73 mg·L_-1 and 8.33 ± 3.62 mg·L_-1 T_1/2, 2.39 ± 0.43 h and 2.20 ± 0.45 h for capsules and tablet respectively. The relative bioavailability of capsules to tablet was 96.9% ± 13.0%. The results of statistical analysis showed that two formulations were bioequivalent.