Study on bioequivalence of calcium dobesilate dispersible tablets in Chinese healthy volunteers

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.