Bioequivalence of oral rosuvastatin calcium capsules in healthy volunteers

Objective To study the bioavailability and bioequivalence of the tested and reference rosuvastatin calcium capsules in healthy male volunteers.Methods According to the crossover design,each volunteer was orally given 10 mg rosuvastatin capsules or tablets.The plasma concentrations were determined by LC/MS/MS.Pharmacokinetic parameters were obtained using DAS program.Results Cmax were(7.32±4.21)ng/ml and(7.37±3.23)ng/ml,Tmax were(4.3±1.3)h and(3.4 ± 1.6)h,T1/2 were(11.57 ± 8.18)h and(10.70 ± 5.26)h,AUC0-t were(64.8±28.0)ng/(ml·h) and(71.0±28.0)ng/(ml·h),AUC0-∞ were(66.1±28.3) and(72.2±28.8)ng/(ml·h),respectively.The relative bioavailability was(93.2±18.5)% in AUC0-t and(93.6±17.6)% in AUC0-∞.The data of the reference and tested drugs were not different as shown by F test.Conclusion The rosuvastatin calcium capsules and rosuvastatin calcium tablets are bioequivalent.