Study of bioequivalence of Ambroxol Hydrochloride Orally Disintegrating Tablets

Objective To study the bioequivalence and relative bioavailability of ambroxol hydrochloride orally disintegrating tablets. Methods 20 healthy male volunteers were taken a single oral administration of 60 mg test and reference tablets,respectively,according to a randomized crossover design.The plasma concentrations of ambroxol were determined by a HPLC/MS/MS method.The pharmacokinetic parameters of the two tablets were calculated. Results Cmax of a single dose of test and reference tablets were (84.7±29.3) and (81.2±28.2) ng·mL-1,tmax were (1.7±0.5) and (1.8±0.4) h,t1/2 were (7.9±0.9) and (8.3±1.0) h,AUC0-24 h were (638.7±180.8) and (591.4±148.3) ng·h·mL-1,respectively.The relative bioavailability of the test tablets was (108.2±16.5) %. Conclusion The two preparations are bioequivalent.