Bioequivalence of Ambroxol Hydrochloride Orally Disintegrating Tablets in Healthy Volunteers

OBJECTIVE:To study the time-concentration curves of single dose of ambroxol hydrochloride orally integrating tablets in healthy volunteers and to evaluate its bioequivalence.METHODS:A single oral dose of 90mg ambroxol hydrochloride orally dissolving tablets and 90 mg ambroxol hydrochloride tablets were given to 18 healthy volunteers by a randomized crossover design.The concentrations of ambroxol hydrochloride in plasma were determined by HPLC.RESULTS:The main pharmacokinetic parameters of the test and references preparations of ambroxol hydrochloride were as follows:Cmax were(169.58±39.43)ng·mL-1 and(170.28±43.26)ng·mL-1;tmax were(1.6±0.5)h and(2.2±0.6)h;t1/2 were(6.77±2.04)h and(6.50±1.27)h;AUC0～24 were(1 131.26±289.36)ng·h·mL-1 and(1 191.54±270.17)ng·h·mL-1;AUC0～∞ were(1 215.27±306.56)ng·h·mL-1 and(1 281.44±291.51)ng·h·mL-1,respectively.The relative bioavailability of the test preparation was(95.5±15.6)%.CONCLUSION:The result demonstrated that the two preparatioins were bioequivalent in absorption degree,suggesting the rapid release characteristics of the preparation.