Study on bioequivalence of domestic ambroxol hydrochloride orally disintegrating tablets and imported tablets in Chinese healthy volunteers

OBJECTIVE To study the bioequivalence of ambroxol hydrochloride orally disintegrating tablets in Chinese healthy volunteers.METHODS 90 mg test preparation and reference preparation were given to 20 male healthy volunteers in randomized two-way crossover design for the pharmacokinetic and relative bioavailability study.Plasma concentrations of ambroxol were determined by HPLC-MS/MS.RESULTS The main pharmacokinetic parameters of the two preparation were:Cmax(175.6±57.3)μg·L-1 and(173.6±50.7)μg·L-1,tmax(1.3±0.3) h and(1.3±0.4)h,AUC0-24(772.1±275.3)μg·L-1·h and(760.3±205.7)μg·L-1·h,AUC0-∞(862.5±300.8)μg·L-1·h and(839.9±241.5)μg·L-1·h,t1/2(ke)(6.8±2.6)and(6.5±2.9) h,respectively.The mean relative bioavailability of test preparation vs reference preparation were(100.3±16.5)%.CONCLUSION The statistical analysis shows that the two preparations are bioequivalent.