Study on Bioequivalence of Ambroxol Hydrochloride Oral Disintegrating Tablets in Healthy Volunteers

OBJECTIVE:To study the bioequivalence of Ambroxol hydrochloride oral disintegrating tablets in healthy volunteers after significant change of manufacturing technology.METHODS:Test preparation and reference preparation each 30 mg were given to 20 male healthy volunteers in randomized two-way crossover design.Blood samples were collected within 48 h after medication using pramipexole as internal standard.Plasma concentrations of ambroxol hydrochloride were determined by LC-MS,and pharmacokinetic parameters were analyzed using DAS 2.0 software.RESULTS:The pharmacokinetics parameters of test preparation and reference preparation were as follows:cmax(84.96±32.46)ng/ml and(90.86±44.81) ng/ml;tmax(1.7±0.7) h and(1.4±0.3) h;AUC0-48 h(678.85±235.17) ng·h/ml and(663.87±214.37)ng·h/ml;t1/2(9.8±1.9) h and(9.7±2.0)h,respectively.There was no significant difference in main pharmacokinetic parameters of them.CONCLUSIONS:Two preparations are bioequivalent after significant change of manufacturing technology.