Bioequivalence of moxifloxacin hydrochloride tablets in healthy Chinese subjects
- Author:
Chang LIU
1
;
Guoping YANG
1
;
Kunhong DENG
2
;
Jie HUANG
2
;
Shuang YANG
2
;
Xiaoyan YANG
2
;
Yuxia XIANG
2
;
Zeyu ZHANG
2
;
Guoping YANG
2
;
Lu HUANG
3
;
Wenzhong LIANG
4
;
Jing LAN
4
Author Information
- Publication Type:Journal Article
- Keywords: Bioequivalence; HPLC-MS/MS; Moxifloxacin hydrochloride; Pharmacokinetics
- From: Chinese Journal of Clinical Pharmacology and Therapeutics 2021;26(12):1393-1399
- CountryChina
- Language:Chinese
- 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: C
