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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.
Single dose study: evaluate safety and tolerability of oral nemonoxacin capsule 500mg
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal function impaired | Experimental | Subject with Severe Impaired Renal Function. Nemonoxacin Malate Capsules 500mg single dose oral |
|
| Healthy Subjects | Experimental | Healthy volunteers. Nemonoxacin Malate Capsules 500mg single dose oral. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nemonoxacin | Drug | Nemonoxacin Malate Capsules 500mg single dose oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function:maximum plasma drug concentration ( Cmax) | Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing | |
| Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: time at which maximum plasma concentration is observed (Tmax) | Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing | |
| Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: area under the plasma concentration vs. time curve (AUC0-t and AUC0-∞) | Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing | |
| Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: elimination half-life (t1/2) | Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing | |
| Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: mean dissolution time(MRT) | Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing | |
| Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: total clearance of the drug from plasma (CLz/F) | Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing | |
| Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: Apparent Volume of Distribution (Vz/F) | Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by AEs | reported spontaneously or not by leading questions | up to 72 hours after study drug dosing |
| Safety assessed by vital signs-respiratory rate | respiratory rate, "times per minute" |
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Inclusion Criteria:
Subjects with kidney impairment
male or female aged 18 to 70 years;
has a body mass index of 17 to 30 kg/m2;
Patients with severe impaired renal function or end-stage renal disease (eGRF≤30ml/min/1.73m2, CKD-EPI estimated),and don't have hemodialysis.
Female volunteers must meet:
Negative pregnancy test prior to enrollment, and Agree with use 1 medical accepted methods of birth control (eg. Hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device) during the whole study and continuing until 1 month after the end of the study, and Non-breastfeeding;
Male volunteers must agree to use medical accepted method of birth control (e.g. barrier contraceptive or sexual partner use the method as (4) above) during the study and through 1month after the end of study;
Agree stay in ward prior to dosing within 48h, and agree not to take coffee, tea, chocolate, alcohol, grapefruit juice, orange juice and other food and drink which contain caffeine and xanthine;
Can sign informed consent form on his own accord;
Can comply with study procedures.
Healthy subjects without renal impairment
Male or female volunteers (matched to a subject with renal impairment in gender);
Aged 18 to 70 years (matched to a subject with renal impairment±5 years, matched range cannot exceed±5 years);
Has a body mass index of 17 to 30 kg/m2(matched to a subject with hepatic impairment±15%,matched range cannot exceed±15%);
Must be in good health as determined by screening medical history, physical examination, vital signs, laboratory test, B ultrasonography and chest X ray;
Renal function is normal (eGFR≥90mL/min/1.73m2)
Female volunteers must meet:
Negative pregnancy test prior to enrollment, and Agree with use 1 medical accepted methods of birth control (eg. Hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device) during the whole study and continuing until 1 month after the end of the study, and Non-breastfeeding;
Male volunteers must agree to use medical accepted method of birth control (e.g. barrier contraceptive or sexual partner use the method as (6) above) during the study and through 1month after the end of study;
Agree stay in ward prior to dosing within 48h, and agree not to take coffee, tea,chocolate, alcohol, grapefruit juice, orange juice and other food and drink which contain caffeine and xanthine;
Can sign informed consent form on his own accord;
Can comply with study procedures
Exclusion Criteria:
Subjects with kidney impairment
Healthy subjects without kidney impairment
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZheJiang Medicine | Recruiting | Shaoxing | China |
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| ID | Term |
|---|---|
| C543520 | nemonoxacin |
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| Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: cumulative amount of unchanged drug excreted into the urine (Ae Urine 0-24h,0-72h) | Within 72h after dosing |
| Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function::renal clearance of the drug from plasma (CLr) | Within 72h after dosing |
| Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function:minimum plasma drug concentration (Cmin) | Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing] |
| up to 72 hours after study drug dosing |
| Safety assessed by vital signs-body temperature | body temperature, "degree centigrade" | up to 72 hours after study drug dosing |
| Safety assessed by vital signs-blood pressure | blood pressure, "mmHg" | up to 72 hours after study drug dosing |
| Safety assessed by vital signs-pulse rate | pulse rate, "beats per minute" | up to 72 hours after study drug dosing |
| Number of Participants with Abnormal Laboratory Values | Hematology, blood biochemistry,cogulation test and urinalysis | up to 72 hours after study drug dosing |
| Safety assessed by physical examination | (1) general appearance (2) skin (3) head and neck (4)chest, including heart, pulmonary and breast (5) abdomen, including stomach and intestines, liver and gallbladder (6) back (7) Urinary tract (8) extremity (9) neurological or psychiatric system (10) lymph gland (11)others. | up to 72 hours after study drug dosing |
| Safety assessed by 12-lead ECGs | up to 72 hours after study drug dosing |