Bioequivalence assessment of ambroxol tablet after a single oral dose administration to healthy male volunteers

A bioequivalence study of the ambroxol hydrochloride tablets was conducted. Twenty-four healthy male Korean volunteers received each medicine at the ambroxol hydrochloride dose of 30 mg in a 2 x 2 cross-over study. There was a 1-week washout period between the doses. Plasma concentrations of ambroxol were monitored by a high-performance liquid chromatography (HPLC) for over a period of 24 h after the administration. AUC(t) (the area under the plasma concentration-time curve from time 0 to last sampling time, 24 h) was calculated by the linear-log trapezoidal rule method. C-max (maximum plasma drug concentration) and T-max (time to reach C-max) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed AUC(t) and C-max, and untransformed T-max. The geometric mean of AUC(t) was 495.8 ng ml(-1) h(-1) (test medication) and 468.3 ng ml(-1) h(-1) (reference medication). C-max of 61.5 and 57.3 ng ml(-1) were achieved for the test and the reference medication, respectively. The point estimates and 90% confidence intervals for AUC(t) (parametric) and C-max (parametric) were, in point estimate (90% confidence interval), 1.058 (0.989-1.134) and 1.073 (1.007-1.142), respectively, satisfying the bioequivalence criteria of the European Committee for Proprietary Medicinal Products and the US Food and Drug Administration Guidelines. The corresponding value of T-max was 0.229 (0.015-0.444). These results indicate that the two medications of ambroxol hydrochloride are bioequivalent and, thus, may be prescribed interchangeably. (C) 2003 Elsevier Ltd. All rights reserved.