盐酸莫西沙星片健康人体生物等效性研究

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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 (T_A), 200 mg*2(T_B) 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 C_max (4.150±1.17) μg/ml,T_max (1.646±0.94) h,AUC_0-t (47.163±6.14) μg·h/ml,AUC_0-∞(50.171±7.01)μg·h/ml. Pharmacokinetic parameters for the T_B were C_max (3.719±0.94) μg/ml,T_max(1.656±0.99) h,AUC_0-t(46.686±6.01) μg·h/ml,AUC_0-∞(49.737±7.15)μg·h/ml. Pharmacokinetic parameters for the RC were C_max (3.827±0.78)μg/ml,T_max(1.625±1.01) h,AUC_0-t(46.281±6.02) μg·h/ml,AUC_0-∞(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 C_max,T_max,AUC_0-t and AUC_0-∞ were between the standard of reference tablets ( 80%-125%).Conclusions The pharmacokinetic parameters of T_A, T_B are conform to the biological equivalent decision criteria compared with RC.

Key words： moxifloxacin bioequivalence healthy body

Received: 09 October 2014

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	Articles by authors
	GUO Zhe
	ZHU Zhe
	SHI Xiaosi
	QIANG Lieying

Cite this article:

GUO Zhe,ZHU Zhe,SHI Xiaosi等. Bioequivalence of moxifloxacin tablets in Chinese healthy volunteers[J]. Med. J. Chin. Peop. Armed Poli. Forc., 2015, 26(3): 221-225.

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http://journal08.magtechjournal.com/Jwk_wjyx/EN/ OR http://journal08.magtechjournal.com/Jwk_wjyx/EN/Y2015/V26/I3/221

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