Abstract：Objective To study the bioequivalence of moxifloxacin tablets (test tablets) compared with the innovator preparation (reference tablets) in Chinese healthy volunteers.Methods Randomized, positive control, open, three-cross clinical trials were performed. 24 healthy subjects were randomized to undergo three crossover oral test drugs including moxifloxacin 400 mg (TA), 200 mg*2(TB) and the reference drug 400 mg (RC). A 4 ml blood sample was taken at every time at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32 and 48 h before and after treatment. The plasma concentration of moxifloxacin was determined by RP- HPLC, fluorescence detection and internal standard - standard curve method. DAS 2.1.1 software was used to calculate the pharmacokinetic parameters and evaluate the bioequivalence. Results Pharmacokinetic parameters for the TA were Cmax (4.150±1.17) μg/ml,Tmax (1.646±0.94) h,AUC0-t (47.163±6.14) μg·h/ml,AUC0-∞(50.171±7.01)μg·h/ml. Pharmacokinetic parameters for the TB were Cmax (3.719±0.94) μg/ml,Tmax(1.656±0.99) h,AUC0-t(46.686±6.01) μg·h/ml,AUC0-∞(49.737±7.15)μg·h/ml. Pharmacokinetic parameters for the RC were Cmax (3.827±0.78)μg/ml,Tmax(1.625±1.01) h,AUC0-t(46.281±6.02) μg·h/ml,AUC0-∞(49.276±6.97)μg·h/ml. The three groups had no statistical difference by the analysis of variance, and the two-way unilateral t-test results showed that the test preparation did not exceed the prescribed upper limit and lower limit of the reference preparation, rejecting null hypothesis (P<0.05). The 90% confidence interval of Cmax,Tmax,AUC0-t and AUC0-∞ were between the standard of reference tablets ( 80%-125%).Conclusions The pharmacokinetic parameters of TA, TB are conform to the biological equivalent decision criteria compared with RC.
张翠莲,Nightingale C H, Nicolau D P. 反相HPLC测定培养基中莫西沙星含量的方法学研究[J].中国药学杂志,2004,39(9):699-701.
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2015, Vol. 26 
