Pharmacokinetics and Safety Study of Levornidazole Disodium Phosphate for Injection in Subjects With Renal Impairment and Normal Renal Impairment

Exclusion criteria

• . Subjects who are known to be allergic to levornidazole phosphate disodium, levornidazole, ornidazole, other nitroimidazoles or their excipients, or have a history of drug or food allergy, or have a history of specific allergic diseases (such as asthma, urticaria, eczema, etc.).
• . Subjects who have special dietary requirements,who cannot accept a unified diet.
• . Subjects who have poor peripheral venous access or cannot tolerate venous puncture or have a history of needle and blood fainting.
• . Subjects who have received renal transplantation and/or require renal dialysis during the study.
• . Subjects combined with cardiovascular, respiratory, digestive, endocrine, malignant tumor, hematopoietic, mental/nervous system serious diseases in addition to the disease causing renal dysfunction itself, which are considered not suitable for participation by the investigator.
• . Subjects with other clinically significant abnormalities except for laboratory tests, physical examination, vital signs, 12-lead electrocardiogram, imaging tests, and abdominal ultrasonography that are judged to be caused by renal insufficiency and its associated diseases, such as ALT (alanine aminotransferase) and/or AST (aspartate aminotransferase) \> 2 times the upper limit of normal and/or TBIL (total bilirubin) \> 1.5 times the upper limit of normal; Hb (hemoglobin) \< 80 g/L; QTc \> 450 ms in men and QTc \> 470 ms in women.
• . Subjects with poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) or heart rate \> 120 bmp.
• . Patients with diabetic nephropathy HbAlc (glycosylated hemoglobin) \> 8.5% or fasting blood glucose \> 8.5 mmol/L, or stable treatment regimen for less than 1 month before screening.