A Pharmacokinetics and Safety Study of Azvudine Tablets in Subjects With Mild-To-Moderate GFR Decline in Renal Insufficiency and in Healthy Subjects

Inclusion Criteria

• •(一) Renal insufficiency study participants and healthy study participants:
• •1. Age ≥ 18 years old and ≤ 70 years old, regardless of gender;
• •2. Body mass index (BMI) within the range of 18.0-30.0 (including the critical value) (BMI = weight (kg) / height 2 (m2)), the weight of men should be ≥ 50.0kg, and the weight of women should be ≥ 45.0kg;
• •3. Females of childbearing potential must have taken reliable and highly effective contraceptive measures and have a negative baseline blood pregnancy test at screening, and are willing to use appropriate and efficient methods of contraception after signing the informed consent form until 3 months after the last dose of the test drug; Male study participants who are willing to do so for the duration of the trial and for 3 months after the last dose of the trial drug Have no plans to have children and voluntarily use highly effective contraception, or have been surgically sterilized;
• •4. Understand and sign the informed consent form.
• •(二) Health study participants (in addition to the above criteria, they should also meet):
• •1. The health condition is judged by the investigator to be good, and the results of vital signs, physical examination, electrocardiogram, and laboratory examination are normal or abnormal, and there is no clinical significance;
• •2. Those who have not taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health care products within 14 days before screening;
• •3. Meet the classification standard of glomerular filtration rate of 90≤GFR\<130 ml/min;
• •4. Study participants with mild or moderate decline in GFR were matched with the following demographic characteristics: age (mean ± 10 years), weight (mean ±10kg), and gender (±1 cases).
• •(三) Renal insufficiency study participants (in addition to the above criteria, they should also meet):
• •1. Stable renal function status: the existing renal function impairment is required to last for more than 3 months, and the GFR results of two tests (with an interval of 72 hours or more) during the screening period are within the same grade and the difference between the two tests is not more than 25%;
• •2. No clinically significant abnormalities were found in the pre-test medical history, vital signs, physical examination, laboratory test items (except ALT and AST, total bilirubin, and direct bilirubin) and test-related examinations and were judged by the clinical research physician to be eligible for enrollment (except for abnormalities related to renal impairment);
• •3. The drug being taken by the study participant with renal insufficiency, which should not affect the absorption, distribution, metabolism or excretion of the study drug, and has been taken at a stable dose for at least 4 consecutive weeks before giving the study drug, and agrees to continue treatment during the study period;
• •4. Two weeks before administration and during the test, Chinese patent medicines, traditional Chinese medicine decoctions, ethnic medicines, SGLT-2i, MRA drugs and benzbromarone are prohibited;
• •5. During the screening period, it is necessary to meet: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), and direct bilirubin (DBIL) all need to \< 1.5 upper limit of normal (ULN)
• •6. Participants in the study of renal insufficiency of all grades met the grading criteria for glomerular filtration rate (GFR was taken as the average of the two tests during the screening period): Mild decrease in GFR: 60≤ GFR≤89 ml/min; Moderate decrease in GFR: 30≤GFR ≤59 ml/min.