Bioequivalence Study of 2 Kinds of Ambroxol Hydrochloride Preparations

OBJECTIVE: To study the bioequivalence of Ambroxol hydrochloride granules and Ambroxol hydrochloride tablets. METHODS: A randomized crossover design was performed in 18 healthy volunteers. In the two study periods, a single oral dose of Ambroxol hydrochloride granules (trial preparation) 60 mg or Ambroxol hydrochloride tablets(reference preparation) 60 mg were administered to each volunteers. Plasma concentrations of ambroxol hydrochloride were measured by HPLC. The pharmacokinetic parameters as well as bioequivalence were measured by 3p97 software. RESULTS: The plasma concentration-time curves of trial preparation and reference preparation were in line with one compartment open model. Main pharmacokinetic parameters of trial preparation vs. reference preparation were as follows: t1/2ke(4.05±1.89) h vs. (4.39±2.14) h; tmax(2.00±0.48) h vs. (1.75±0.71) h; cmax(154.59±65.64) ng·mL-1 vs. (153.95±70.21) ng·mL-1; AUC0～24(954.96±419.86)ng·h·mL-1 vs.(951.63±463.38)ng·h·mL-1; AUC0～∞(1 098.64±469.63) ng·h·mL-1 vs. (1 158.98±505.57) ng·h·mL-1 respectively. The relative bioavailability of Ambroxol hydrochloride granule was(100.35±14.82)%. Results of variance analysis, t-test and (1-2α)confidence interval showed that there was no significant difference in pharmacokinetic parameters (P0.05). CONCLUSION: The result of statistical analysis shows that the two preparations are bioequivalent.