Pharmacokinetics And Bioequivalence Of Moxifloxacin Hydrochloride Tablets In Chinese Healthy Volunteers After Fasting And Fed Conditions

Objective: A high performance liquid chromatography mass spectrometry(HPLC-MS/MS)method was established for the determination of moxifloxacin in human plasma.The pharmacokinetics and the bioequivalence of moxifloxacin were studied under fasting and fed conditions.Methods: Recruit 24 Chinese healthy volunteers,using single dose,open,randomized,two crossover design,a single oral dose of moxifloxacin were 0.4 g(T)test preparation and reference preparation(R)of 0.4 g,the cleaning period for two weeks,the concentration of moxifloxacin in the plasma of healthy subjects was determined by HPLC-MS/MS,using Win Nonlin 6.1 to calculate the pharmacokinetic parameters and evaluate the bioequivalence of the tested preparation and the reference preparation.Results: The main pharmacokinetic parameters of a single oral moxifloxacin tablet under the fasting condition were as follows respectively T and R :Cmax(3.72±0.83)μg?m L-1、(3.51±0.69)μg?m L-1;tmax(1.63±1.52)h、(1.81±1.18)h;t1/2(11.81±1.66)h、(11.54±1.26)h;AUC0-48h(52.49±10.87)μg?h-1?m L-1、(51.93±10.31)μg?h-1?m L-1;AUC0-￥(56.05 ± 11.57)μg?h-1?m L-1 、(55.17 ± 11.04)μg?h-1?m L-1;The main pharmacokinetic parameters of a single oral moxifloxacin tablet under fed conditions were as follows respectively T and R :Cmax(3.05±0.46)μg?m L-1、(3.03±0.61)μg?m L-1;tmax(2.52±1.40)h、(2.62±1.23)h;t1/2(12.21±1.87)h、(12.13±2.04)h;AUC0-48h(44.52±7.13)μg?h-1?m L-1、(45.93±9.09)μg?h-1?m L-1;AUC0-￥(47.73±8.09)μg?h-1?m L-1、(49.31±10.07)μg?h-1?m L-1.Conclusion: Under the condition of fasting and fed,the bioequivalence of the domestic Moxifloxacin Hydrochloride Tablets test preparation and the imported Moxifloxacin Hydrochloride Tablets reference preparation is similar to the bioequivalence of the major pharmacokinetic parameters.