NCT02604498

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Zhejiang Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

Conditions

• Liver Dysfunction

Interventions

Type	Name	Description
DRUG	Nemonoxacin	Single dose 500mg oral

Timeline

• Start date: 2016-04-14
• Primary completion: 2018-01-15
• Completion: 2018-01-15
• First posted: 2015-11-13
• Last updated: 2018-03-30

Locations

1 site across 1 country: China