Bioequivalence and safety evaluation of moxifloxacin hydrochloride tablets in healthy volunteers
10.13699/j.cnki.1001-6821.2015.24.014
- VernacularTitle:盐酸莫西沙星在中国成年健康志愿者的生物等效性研究
- Author:
Shu-Min WANG
1
;
Hui ZHOU
;
Shao-Jie GUO
;
Feng WU
;
Si-Yang NI
;
Xiu-Li ZHAO
;
Yun-Xia CHAN
;
Yu-Xian GENG
Author Information
1. 首都医科大学 附属北京同仁医院 国家药物临床试验机构
- Keywords:
moxifloxacin;
bioequivalence;
safety evaluation
- From:
The Chinese Journal of Clinical Pharmacology
2015;(24):2414-2416,2436
- CountryChina
- Language:Chinese
-
Abstract:
Objective To study pharmacokinetic behaviors of moxifloxa-cin in Chinese healthy volunteers and to evaluate the bioequivalence of 2 kinds of moxifloxacin hydrochloride tablets.Methods In randomized crossover study, 22 healthy male volunteers were given single oral dose of test and reference preparation of moxifloxacin tablet ( each 0.4 g ) .The concentration of moxifloxacin in human plasma was measured by LC/MS/MS.Main pharmacokinetic parameters were calculated by using WinNonlin 6.3 software.Results Main pharmacokinetic parameters of test and reference preparation were as follow: t1/2 were (14.91 ±2.56) and(14.68 ±2.02)h, tmax were (1.26 ±0.89)and (1.09 ±0.73) h, Cmax were (1914.84 ±461.20) and (1877.52 ±559.80) ng? mL-1, AUC0-t were ( 27406.96 ±7060.97 ) and ( 27414.48 ±6745.13 ) ng? mL-1? h, AUC0-∞ were ( 28361.29 ± 2409.57 ) and (28353.74 ±6883.95)ng? mL-1? h, respectively. The relative bioavailability of test preparation was(100.34 ±8.69)%.Conclusion Two kinds of moxifloxacin hydrochloride tablets are bioequivalent.
