NCT02604498

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

Completed Phase 1 Last updated 30 March 2018

What this trial tests

Phase 1 trial testing Nemonoxacin in Liver Dysfunction in 20 participants. Completed in 15 January 2018.

Timeline

14 April 2016

Primary endpoint
15 January 2018

15 January 2018

Quick facts

Lead sponsor	Zhejiang Medicine Co., Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	20
Start date	14 April 2016
Primary completion	15 January 2018
Estimated completion	15 January 2018
Sites	1 location across China

Drugs / interventions tested

• Nemonoxacin (NEMONOXACIN) — full drug profile →

Conditions studied

• Liver Dysfunction — all drugs for Liver Dysfunction →

Sponsor

Zhejiang Medicine Co., Ltd. — full company profile →

Who can join

Adults 18 to 70, any sex, with Liver Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Population Pharmacokinetics Study of Nemonoxacin Among Chinese Patients With Moderate Hepatic Impairment.
   Kang Y, Li Y, Xu F, Zhang J, et al · · 2019 · cited 6× · PMID 30819510 · DOI 10.1016/j.clinthera.2019.01.015