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%).