Study on bioequivalence of calcium dobesilate dispersible tablets in Chinese healthy volunteers
Lu Huang, Ge Miaomiao, Shu Cheng-ren, Weiyong Li · Chinese Journal of Hospital Pharmacy · 2010
OBJECTIVE To evaluate the bioequivalence of calcium dobesilate dispersible tablets and calcium dobesilate tablets in Chinese healthy volunteers.METHODS The concentrations of calcium dobesilate in plasma were determined by HPLC-fluorescence detection after 19 healthy male volunteers received a single dose of test dispersible tablets and reference tablets in twotreatment,two-period,crossover design.RESULTS The main pharmacokinetic parameters of calcium dobesilate were as follows:AUC0→twere(87.5±15.6)mg·h·L-1 and(82.9±13.9)mg·h·L-1;AUC0→∞were(91.4±17.6)mg·h·L-1 and(86.5± 15.4)mg·h·L-1;Cmaxwere(10.9±3.1)mg·L-1 and(10.3±2.3)mg·L-1;tmaxwere(4.0±1.1)h and(4.4±1.4)h;t1/2were(4.3±1.6)h and(4.7±1.4)h,respectively.The relative bioavailability of calcium dobesilate dispersible tablets to calcium dobesilate tablets was(106.8±17.5)%.CONCLUSION The results of statistic analysis show that two preparations of calcium dobesilate were bioequivalent.