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

Pharmacol Res. 2004 Jan;49(1):93-8. doi: 10.1016/j.phrs.2003.07.011.

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 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 24h after the administration. AUC(t) (the area under the plasma concentration-time curve from time 0 to last sampling time, 24h) 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.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral*
  • Adult
  • Ambroxol / administration & dosage*
  • Ambroxol / blood
  • Ambroxol / pharmacokinetics
  • Area Under Curve
  • Biological Availability
  • Chromatography, High Pressure Liquid / methods
  • Cross-Over Studies
  • Half-Life
  • Humans
  • Male
  • Pectins / chemistry
  • Tablets* / chemistry
  • Therapeutic Equivalency*
  • Time Factors

Substances

  • Tablets
  • Ambroxol
  • Pectins