Effect of Ambroxol on Plasma Concentration and Pharmacokinetic Parameters of Roxithromycin / 中国药房

ABSTRACT

OBJECTIVE:To evaluate the effect of ambroxol on plasma concentration and pharmacokinetic parameters of roxithromycin when healthy volunteers received roxithromycin and ambroxol. METHODS: In double-period cross-over experiment, 24 healthy male volunteers received roxithromycin tablets or roxithromycin tablets combined with ambroxol tablets. Serial venous blood samples were collected at different time points after drug administration. Plasma concentrations of roxithromycin were measured by LC-MS. The pharmacokinetic parameters of roxithromycin were calculated and analyzed by variance analysis. Drug interaction was detected by 90% confidence interval. RESULTS: Main pharmacokinetic parameters of roxithromycin tablets and drug combination were as follows tmax(1.67?0.32)h vs. (1.67?0.41)h; Cmax(10.26?2.82) mg?L-1 vs. (10.86?3.19) mg?L-1; AUC0～72(110.19?35.18) mg?h?L-1 vs. (113.42?38.72)mg?h?L-1; AUC0～∞(111.70?36.23) mg?h?L-1 vs. (115.04?39.98) mg?h?L-1. CONCLUSION:? Ambroxol has no effect on the plasma concentration and pharmacokinetics of roxithromycin in healthy volunteers.