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

Abstract

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 2×2 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.