Bioequivalence of ambroxol hydrochloride sustained-release tablets in healthy volunteers

Objective:To study the bioequivalence of ambroxol hydrochloride sustained-release tablets to the reference.Methods:A single oral dose(75 mg tested and reference formulation)was given to 20 healthy volunteers in a randomised crossover study.The concentrations of ambroxol hydrochloride sustained-release tablets in plasma were determined by HPLC.Results:After a single dose,the pharmaco kinetic parameters for ambroxol hydrochloride sustained-release tablets as compared with those of the reference were as follows:Cmax:(78.19±11.60)and(77.26±18.50)ng/ml;Tmax:(5.00±1.16)and(5.00±1.16)h;AUC(0~36h):(1234.70±58.50)and(1150.10±265.48)(ng/ml).h,AUC(0-in)f:(1505.74±208.10)and(1381.25±364.37)(ng/ml).h.The 90% confidential intervals of Cmax,AUC(0~36h)and AUC(0-in)fof tested formulation were 76.8%~125.6%,87.5%~109.1%,101.4%~120.3%,respectively.Conclusion:The relative bioavailability is(113.4±35.3)%.The results of the statistic analysis show that the two formulations are bioequivalent.