Pharmacokinetics Study of Nemonoxacin Malate Capsules in Subjects With Severe Impaired Renal Function
Status:
Unknown status
Trial end date:
2019-01-01
Target enrollment:
Participant gender:
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.