Bioequivalence of Domestic and Imported Ambroxol Hydrochloride Tablets in Health Volunteers

Objective To study the bioequivalence of ambroxol hydrochloride tablets. Methods A single oral administration of 90mg domestic and imported ambroxol hydrochloride tablets was given to 9 healthy male volunteers in the randomized crossover study. A high performance liquid chromatographic method was developed to determine the concentration of ambroxol hydrochloride in human plasma. The data were analyzed by the 3p87 program. Results The pharmacokinetic parameters after a single oral administration of 90mg domestic and imported tablets were as follows: AUC were 2340.42±448.04 and 2363.55±448.86ng·h/ml; C max were 211.76±70.71 and 226.53±34.59ng/ml; t max were 2.22±1.65 and 1.82±0.80h; t 1/2ke were 6.08±1.02 and 6.27±0.66h, respectively. The above parameters obtained from two formulations were compared by the analysis of variance and no significant difference was found( P 0.05). The bioequivalence of two formulations was assessed by a two one-sided test. Compared with the reference formulation, relative bioavailability of the test formulation was (99.65± 10.65)%. Conclusion The test formulation is bioequivalent with the reference.