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Pharmacokinetics Study of Nemonoxacin Malate Capsules in Subjects With Moderate Impaired Hepatic Function

Liver Dysfunction Clinical Trial

Official title:
Pharmacokinetics Study of Nemonoxacin Malate Capsules in Subjects With Moderate Impaired Hepatic Function

Clinical Trial Summary

This is a single center, open-label, non-randomized, 1:1 parallel control and single dose administration study design. Healthy subjects will be matched to moderate hepatic function impaired (Child-Pugh B，7-9) subjects in age, gender and weight as parallel control, which matches healthy with normal hepatic function according to the of subjects with impaired hepatic function as, after enrollment of subjects with moderate impaired hepatic function (Child-Pugh B，7-9). Hepatic function impaired group and control group both receive orally single-dose of nemonoxacin malate capsule (0.5g). Collect the blood and urine samples before and after the administration to perform pharmacokinetic analysis and safety observation.

Clinical Trial Description

Single dose study: evaluate safety and tolerability of oral nemonoxacin capsule 500mg. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02604498
Study type Interventional
Source Zhejiang Medicine Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date April 14, 2016
Completion date January 15, 2018
View Details
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