Eligibility Criteria
The main inclusion criteria included male or female volunteers aged 18
to 75 years, body mass index (BMI)
of 17-30 kg/m2. Volunteers agreed to use an acceptable
contraception method throughout the study and until one month after the
end of study. The nondialysis-dependent patients with severely impaired
renal function or ESRD were eligible for enrolment into severe renal
impairment group. The healthy controls were matched to the patients with
severe renal impairment in terms of age (±5 years), sex, and BMI
(±15%). A healthy status was determined according to the evaluation of
medical history, physical examination, 12-lead ECG, and laboratory
tests. Consumption of any caffeine-containing product or xanthine was
forbidden from 48 hours predose to the end of treatment period.
The subjects were excluded if they had any of the following: an allergic
constitution, known or suspected hypersensitivity to quinolones;
positive urine test for drugs or alcohol; smoker; use of any
investigational drug; positive test for
hepatitis B surface antigen,
hepatitis C virus,
human immunodeficiency virus, or
syphilis rapid plasma reagin; use
of inhibitor or inducer of hepatic cytochrome metabolism enzymes, or
other drugs probably affecting the PK profile of nemonoxacin. The
subjects with a history of acute or chronic disease, including chronic
liver, renal, cardiovascular, neurologic, psychiatric, gastrointestinal,
pulmonary, urinary, or endocrine disease, were excluded from healthy
control group. Clinically significant abnormal 12-lead ECG and abnormal
laboratory test result also precluded subject enrollment. The subjects
with sere renal impairment or ESRD were considered clinically stable
except the case of moderate or severe anemia (hemoglobin < 60
g/L), severe hypertension (diastolic blood pressure > 110
mmHg or systolic blood pressure > 180 mmHg), diabetic
nephropathy, urinary incontinence, anuria, or significant increase of
serum creatinine from baseline (≥
30%).