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;
Parallel
Azvudine tablets
DrugOn 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.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Azvudine
Cmax will be calculated by measuring the concentration of Azvudine in blood samples and urine samples.
Pharmacokinetics (PK): Area Under the Concentration-Time Curve from the First Dose to the Last Blood Collection Point (AUC0-t) of Azvudine
AUC0-t will be calculated by measuring the concentration of Azvudine in blood samples and urine samples.
Pharmacokinetics (PK): Area Under the Concentration-Time Curve Extrapolated from the Initial Administration to Infinity (AUC0-∞) of Azvudine (if applicable)
AUC0-∞ will be calculated by measuring the concentration of Azvudine in blood samples and urine samples.
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Azvudine
Tmax will be calculated by measuring the concentration of Azvudine in blood samples and urine samples.
Pharmacokinetics (PK): Elimination Half-life (t1/2) of Azvudine
t1/2 will be calculated by measuring the concentration of Azvudine in blood samples and urine samples.
Occurrence of Adverse Events
Clinical presentation characteristics, severity, onset time, duration of adverse events, management measures, outcomes, and the correlation with the investigational drug.
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