NCT02840812

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• 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 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.

Detailed description

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

Conditions

• Kidney Dysfunction

Interventions

Type	Name	Description
DRUG	Nemonoxacin	Nemonoxacin Malate Capsules 500mg single dose oral

Timeline

• Start date: 2017-04-05
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2016-07-21
• Last updated: 2018-04-03

Locations

1 site across 1 country: China