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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2021, Vol. 26 ›› Issue (12): 1393-1399.doi: 10.12092/j.issn.1009-2501.2021.12.008

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Bioequivalence of moxifloxacin hydrochloride tablets in healthy Chinese subjects

LIU Chang1, DENG Kunhong2, HUANG Jie2, YANG Shuang2, YANG Xiaoyan2, XIANG Yuxia2, HUANG Lu3, ZHANG Zeyu2, LIANG Wenzhong4, LAN Jing4, YANG Guoping1,2   

  1. 1XiangYa School of Pharmaceutical Sciences, Central South University, Changsha 410013, Hunan, China; 2Center of Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha 410013, Hunan, China; 3Department of Pharmacy, the Third Xiangya Hospital, Central South University, Changsha 410013, Hunan, China; 4Shanghai WuXi AppTec Co.,Ltd., Shanghai 200131, China
  • Received:2021-09-18 Revised:2021-10-13 Online:2021-12-26 Published:2022-01-07

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Abstract: AIM: To study the pharmacokinetic characteristics of single-dose oral moxifloxacin hydrochloride tablets under fasting and fed conditions, and use moxifloxacin hydrochloride tablets produced by Bayer Pharma AG as a reference to compare the pharmacokinetic parameters of the two preparations, and evaluate the human bioequivalence of the two preparations.  METHODS: A single-center, randomized, open, two-period, and self-crossover design was adopted to conduct a fasting and fed bioequivalence study of 23 healthy subjects each. The 0.4 g dose preparations were taken orally per cycle on fasting or fed administration. The plasma concentrations of moxifloxacin at different times after administration were determined by HPLC-MS/MS. The main pharmacokinetic parameters were calculated, and the bioavailability of the test preparation relative to the reference preparation was evaluated. RESULTS: After subjects in the fasting group took the test preparation T and the reference preparation R, the main pharmacokinetic parameters of moxifloxacin hydrochloride were: Cmax (3 476.0±855.2), (3 632.6±1 011.3) ng/mL; Tmax 1.50 (0.25, 4.00), 2.50 (0.25, 4.00) h; AUC0-t (54 972.81±11 400.81), (56 757.41±12 670.53) h·ng·mL-1; AUC0-∞ (56 791.17±11 681.08), (58 574.37±13 072.17) h·ng·mL-1; T1/2 (14.13±2.40), (13.85±2.44) h. After the subjects in the fed group took the test parameter T and the reference parameter R, the main pharmacokinetic parameters of moxifloxacin hydrochloride were: Cmax (3 744.3±819.2), (3 569.1±653.8) ng/mL; Tmax 1.50 (0.50, 4.00), 1.50 (0.50, 4.00) h; AUC0-t (51 613.98±10 725.93), (52 322.70±10 189.50) h·ng·mL-1; AUC0-∞ (53 585.13±10 954.51), (54 207.13±10 313.28) h·ng·mL-1; T1/2 (14.47±3.71), (14.53±3.04) h. The 90%CI of Cmax, AUC0-t, AUC0-∞ geometric mean ratios of the fasting group and the fed group all fell between 80.00%-125.00%. CONCLUSION: The test preparation T and the reference preparation R under fasting and fed conditions are bioequivalent and safe.

Key words: moxifloxacin hydrochloride, bioequivalence, pharmacokinetics, HPLC-MS/MS

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