Tolerance of soxifloxacin hydrochloride tablet after ascending single dose in Chinese healthy subjects
10.13699/j.cnki.1001-6821.2015.16.015
- VernacularTitle:盐酸索西沙星片在健康人体单次给药的耐受性
- Author:
Cai-Yun ZHAO
1
;
Yuan LV
;
Fang HOU
;
Jin WANG
;
Ya-Hong XIA
;
Yan MA
;
Ji-Hong TIAN
;
Yan LIU
;
Yu-Xin ZHANG
;
Wei MAO
;
Ya-Qin HUANG
Author Information
1. 北京大学 第一医院 临床药理研究所
- Keywords:
soxifloxacin hydrochloride;
single oral dose;
tolerance
- From:
The Chinese Journal of Clinical Pharmacology
2015;(16):1606-1609
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the safety and tolerance of single oral dose of soxifloxacin hydrochloride in Chinese healthy subjects.Methods Seventy-two eligible subjects were randomized into 7 escalation dose groups.Eight subjects in 50 mg group were randomized to receive either study drug or placebo in the ratio of 3 to 1;each ten subjects in 100 mg, 200 mg and 300 mg group received study drug to placebo was 4∶1, respectively.Twelve subjects in 400mg and 600mg group, the ratio of study drug to placebo was 2∶1 , and ten subjects in 800 mg group was 3∶2, respectively.Safety and tolerability were evaluated by monitoring adverse events, laboratory parameters, electrocardiography and electroen-cephalogram. Results A total of 72 subjects finished study. One subject in 400 mg group had bruise on the left ankle with creatine kinase elevated, considered not related to study drug, the other one in 600 mg group complained mild dizziness and two subjects in 800 mg group complained mild nausea.All of these symptoms were assessed as related to study drug.Conclusion Soxifloxacin hydrochloride was safe and well tolerated after single oral administration at dose range of 50 to 800 mg.
