This study adopts a non-randomized, open label, parallel, single-dose design to evaluate the safety and pharmacokinetic characteristics of Buagafuran capsules in participants with hepatic impairment.
Voluntarily sign an informed consent form before the start of activities related to this trial, understand the procedures and methods of this trial, and be willing to strictly follow the clinical trial protocol to complete this trial;
Participants (including partners) are willing to have no fertility plans from screening to within 6 months after the last administration of the study drug, and voluntarily adopt highly effective contraceptive measures;
On the day of signing the informed consent form, the age range is 18 to 70 years old (including both ends), and both males and females are eligible;
Male participants should weigh no less than 50 kg, and female participants should weigh no less than 45 kg; Body Mass Index (BMI) should be between 18 and 32 kg/m2 (including both ends), with BMI=weight (kg)/height (m2);
Allergic constitution, including individuals with a history of severe drug allergies or drug hypersensitivity reactions, known to be allergic to the study drug or any component of the study drug;
During the screening period, the electrocardiogram showed a QTc interval of>470 milliseconds in males and>480 milliseconds in females;
Individuals with a history of swallowing difficulties or any gastrointestinal diseases that affect drug absorption, including frequent nausea or vomiting caused by any underlying cause;
Those who need treatment for bacterial, viral, parasitic or fungal infection with any clinical symptoms during screening (excluding hepatitis B and hepatitis C), and those who have a history of serious active infection within 1 month before screening;
Parallel
Buagafuran
Drugparticipants to receive Buagafuran capsules 30 mg on an empty stomach on the morning of Day1
Pharmacokinetics of Buagafuran(Cmax)
Maximum observed plasma concentration
Pharmacokinetics of Buagafuran(AUC0-t)
Area under the plasma concentration-time curve from time 0 to time of the last measurable concentration
Pharmacokinetics of Buagafuran(AUC0-inf)
Area under the plasma concentration-time curve from time 0 to infinity
incidence of Adverse Events
To evaluate the safety of a single dose of 30mg Buagafuran administered in participants with hepatic impairment
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This trial is not recruiting at the moment. You can still explore other options:
