This study is a Phase I, single-dose, open-label trial designed to evaluate the pharmacokinetics and safety of a single oral dose of 25 mg VC005 tablets in participants with renal impairment compared to participants with normal renal function.
Voluntarily sign the informed consent form prior to the trial, fully understand the trial content, procedures, and possible adverse reactions, and be able to complete the study in accordance with the protocol requirements;
Participants (including their partners) are willing to have no pregnancy plan from screening until 3 months after the last study drug administration and voluntarily take effective contraceptive measures; and have no plans to donate sperm or eggs;
Male and female participants aged 18 to 70 years (inclusive);
Male participants weighing no less than 50.0 kg, female participants weighing no less than 45.0 kg. Body mass index (BMI) between 18 and 32 kg/m² (inclusive).
History of allergies, including to drugs, food, dust mites, etc., known allergy to the study drug or any of its components;
History of drug abuse, drug addiction and/or alcohol abuse (consumption of 14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine); positive results in drug abuse screening and alcohol screening;
Blood donation or significant blood loss (> 400 mL) within 3 months prior to screening; or plan to donate blood during the trial;
Average daily smoking of more than 5 cigarettes within 3 months prior to screening; or inability to stop using any tobacco products during the trial;
Parallel
VC005 Tablets
DrugOral single dose
Area under the plasma concentration-time curve(AUC）
Maximum Observed Plasma Concentration (Cmax)
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
