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

2003; Elsevier BV; Volume: 49; Issue: 1 Linguagem: Inglês

10.1016/j.phrs.2003.07.011

1096-1186

Hee Joo Lee, Sun Koung Joung, Yoon Gyoon Kim, Jeong-Yeon Yoo, Sang Beom Han,

Pesticide Residue Analysis and Safety

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. AUCt (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. Cmax (maximum plasma drug concentration) and Tmax (time to reach Cmax) were compiled from the plasma concentration–time data. Analysis of variance was carried out using logarithmically transformed AUCt and Cmax, and untransformed Tmax. The geometric mean of AUCt was 495.8 ng ml−1 h−1 (test medication) and 468.3 ng ml−1 h−1 (reference medication). Cmax 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 AUCt (parametric) and Cmax (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 Tmax 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.