Tolerance of antofloxacin hydrochloride tablet after high single oral dose in Chinese healthy subjects
10.13699/j.cnki.1001-6821.2015.14.016
- VernacularTitle:单次口服高剂量盐酸安妥沙星片在健康人体的耐受性研究
- Author:
Cai-Yun ZHAO
1
;
LüYuan
;
Jin WANG
;
Ya-Hong XIA
;
Yan MA
;
Ji-Hong TIAN
;
Yan LIU
;
Yu-Xing ZHANG
Author Information
1. 北京大学 第一医院 临床药理研究所
- Keywords:
antofloxacin hydrochloride;
high dose;
single oral dose;
tolerance
- From:
The Chinese Journal of Clinical Pharmacology
2015;(14):1407-1410
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the safety and tolerance of antofloxa-cin after high single oral dose in Chinese healthy subjects. Methods Thirty subjects were randomized into three dose groups (600, 800 and 1000 mg ) , each dose groups of eight subjects received study drug, otherwise two subjects in each group received placebo.Safety and tolerability were evaluated by monitoring adverse events, laboratory parameters, electrocardiography ( ECG ) and electroencephalogram ( EEG) .Results Totally 30 subjects finished study.No adverse event in 600 mg group.There were three subjects had 5 adverse events in 800 mg group, complained nausea and vomiting, considered related to study drug.In 1000 mg group, six subjects had 10 adverse events, including nausea, vomiting, dizziness and dot erythema of feet, related or probably related to study drug.There was no adverse event in placebo group. Conclusion After high single oral administration of antofloxacin hydrochloride, 600 mg was safe clinical maximum dose.
