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Pharmacokinetics Study of Nemonoxacin Malate Capsules in Subjects With Severe Impaired Renal Function

Kidney Dysfunction Clinical Trial

Official title:
Pharmacokinetics Study of Nemonoxacin Malate Capsules in Subjects With Severe Impaired Renal 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 severe renal function impaired (eGFR≤30mL/min/1.73m2，CKD-EPI estimated) subjects in age, gender and weight as parallel control, which matches healthy with normal renal function according to the of subjects with impaired renal function as, after enrollment of subjects with severe impaired renal function (eGFR≤30mL/min/1.73m2，CKD-EPI estimated). Renal 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 NCT02840812
Study type Interventional
Source Zhejiang Medicine Co., Ltd.
Contact
Status Recruiting
Phase Phase 1
Start date April 5, 2017
Completion date January 2019
View Details
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