Pharmacokinetics and Bioequivalence of Ambroxol Hydrochloride Granules

The pharmacokinetics of ambroxol hydrochloride granules and reference tablets were investigated at a single oral dosage of 30mg in 19 healthy male volunteers,according to a randomized crossover design.The concentration of ambroxol in plasma was determined by a LC-MS/MS method.The main pharmacokinetic parameters of test and reference preparations were cmax(69.66±22.12) and(67.89±25.08)ng/ml,tmax(1.95±0.60) and(1.89±0.43)h,t1/2(7.77±0.93) and(7.61±1.02)h,AUC0→24h(517.9±180.4) and(518.3±215.5)ng.h.ml–1.The relative bioavailability of ambroxol hydrochloride granules was(102.7±17.1)%.The result of two one-side t test showed that the two preparations were bioequivalent.