A Study on Relative Bioavailability and Bioequivalence of Rapid Oral Disintegrating Tablets of Ambroxol Hydrochloride in Chinese Healthy Volunteers

Objective To study the pharmacokinetics and relative bioavailability of rapid oral disintegrating tablets of ambroxol hydrochloride in Chinese healthy volunteers.Methods Eighteen healthy volunteers were divided into 2 groups(n=9)randomizedly.Rapid oral disintegrating or common ambroxol hydrochloride tablets were given to volunteers respectively in an open cross-over pattern.The concentration of ambroxol hydrochloride in plasma was determined by HPLC at different time points after a single oral dose of 90 mg.The pharmacokinetic parameters and relative bioavailability were evaluated to analyse the bioequivalence of 2 differents drug forms.Results Main pharmacokinetic parameters in the test preparation and the reference preparation were as follow:tmax were(1.3±0.6)and(1.5 ± 0.9)h;Cmax were(195.20 ±57.24)and(177.80 ±50.33)ng·mL-1;t1/2 were(6.69 ±1.75)and(6.91±1.57)h;AUC0-24 were(1 186.54±321.35)and(1 215.64±368.93)ng·h-1·mL-1;AUC0-∞ were(1 375.05±388.37)and(1 371.22±419.52)ng·h-1·mL-1,respectively.The relative bioavailability of the test preparation was(102.1±29.8)%.Conclusion The results showed that two preparation forms were bioequivalent.