Azvudine(FNC)，a nucleoside reverse transcriptase inhibitor, make itself a better candidate to be co-formulated in other anti-HIV therapies, thus to improve patient's compliance. FNC is a broad-spectrum RNA virus inhibitor that inhibits the novel coronavirus RNA-dependent RNA polymerase.
This trial uses a non-randomized, open-label, parallel, single-dose adaptive design aimed at investigating the effects of varying degrees of renal insufficiency on the pharmacokinetics, safety, and tolerability of a single oral dose of 3 mg Azvudine tablets in humans. On the first day of the study, a single oral dose of 3 mg ( 3 tablets ) of Azvudine tablets is taken orally on an empty stomach. Biological sample collection and safety examination will be performed in this trial.
Age ≥ 18 years old and ≤ 70 years old, regardless of gender;
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;
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;
Understand and sign the informed consent form.
Allergies, especially those who are allergic to any of the ingredients in this product and excipients;
Those who have undergone gastrointestinal resection in the past, or suffer from digestive diseases that will affect the absorption, distribution, metabolism and excretion of drugs;
Those who have a history of drug abuse within 12 months before screening or those who have tested positive for addictive substances before enrollment;
Those with fever or infectious diseases at the time of screening;