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 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.
Department of Pharmacokinetics, Seoul Medical Science Institutes, 7-14 Dongbinggo-Dong, Yongsan-Gu, Seoul 140-809, South Korea. hjlee@bio-core.com
Hee Joo
HJ
Lee
Sun Koung
SK
Joung
Yoon Gyoon
YG
Kim
Jeong-Yeon
JY
Yoo
Sang Beom
SB
Han
D000284:Administration, Oral; D000328:Adult; D000551:Ambroxol / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics; D019540:Area Under Curve; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D018592:Cross-Over Studies; D006207:Half-Life; D006801:Humans; D008297:Male; D010368:Pectins / Q000737:chemistry; D013607:Tablets / Q000737:chemistry; D013810:Therapeutic Equivalency; D013997:Time Factors
D013607:Tablets; D000551:Ambroxol; D010368:Pectins