A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Rongliflozin in Type 2 Diabetic Subjects With Renal Impairment

Exclusion Criteria

• •Known allergy to sodium-glucose cotransporter 2 (SGLT2) inhibitor drugs or related excipients.
• •In the 3 months before screening, those who smoked more than 5 cigarettes per day on average or who could not give up smoking from signing informed consent to leaving the group.
• •Have a history of alcoholism.
• •Ingested any food or drink containing caffeine, xanthine, alcohol, grapefruit within 48 hours before taking the test drug.
• •Those who donate blood or lose a lot of blood (\>400 mL) within 3 months before taking the test drug, or have a history of blood transfusion within 1 month before screening, or plan to donate blood within 1 month after the end of the trial.
• •Those who have taken the trial drug or such drugs within 1 month before taking the trial drug, or participated in the clinical trial of any drug or medical device within 3 months before screening.
• •Those who have a positive urine drug screen or have a history of drug abuse or drug use in the past 5 years.
• •The subject is breastfeeding or the serum pregnancy test result is positive.
• •Subjects had undergone surgery within 1 month before screening, or major surgery was planned during the study period.
• •Have severe mental illness or language barrier, unwilling or unable to fully understand and cooperate.
• •History or evidence of other diseases, such as history of repeated urinary tract infections, poorly controlled high blood pressure, type I diabetes, urinary incontinence, etc.
• •Abnormal laboratory tests, such as a) Alanine transaminase (ALT)/Aspartate aminotransferase (AST)\>2.0×UNL and/or total bilirubin\>1.5×UNL; b) hemoglobin \<100 g/L; c) hepatitis B surface antigen positive, hepatitis C antibody positive, HIV antibody positive , Syphilis antibody positive.
• •The researcher believes that the subject has any situation that may interfere with the interpretation of the pharmacokinetics, efficacy and safety data of this study.
• •Subjects considered by the researcher to be unsuitable to participate in this trial.