Bioequivalence of ambroxol hydrochloride orally disintegrating tablets in healthy volunteers

AIM To study the bioequivalence between test drug(ambroxol hydrochloride orally disintegrating tablets) and its reference drug(ambroxol).METHODS A single dose of 90 mg test drug and reference drug were given to 19 healthy male volunteers.HPLC method was developed to determine the concentrations of ambroxol in human plasma.The data were analyzed by the BAPP 2.0 program.RESULTS The main pharmacokinetic parameters of test drug and its reference drug were as follows:ρmax were(168.34±41.16)μg·L-1 and(168.60±46.40)μg·L-1;tmax were (1.6±0.5)h and(2.2±0.7)h.t12 were (6.21±1.75)h and(6.31±1.99)h.AUC0→24 were(1 171.65±372.37)μg·h·L-1 and(1 115.81±342.11)μg·h·L-1,respectively.The relative bioavailability of test drug was(106.2±19.6)%.CONCLUSION The results of statistical analysis for the ρmax and AUC0→24 show that the two preparations are bioequivalent.There are singnificant differences in tmax between two preparations and the ambroxol hydrochloride orally disintegrating tablets are absorbed faster.