Use these resources to provide understandable information about this study to patients, families, and health care providers:This study is a multi-center, non-randomized, open-label, parallel-group, multiple-dose Phase I clinical trial evaluating the pharmacokinetic characteristics of ammoxetine hydrochloride enteric-coated tablets in participants with mild hepatic impairment (Child-Pugh Class A), moderate hepatic impairment (Child-Pugh Class B), and participants with normal liver function who are matched for age, weight, and gender. Participants in all groups receive 20 mg of ammoxetine hydrochloride enteric-coated tablets daily at 1 hour after meals, from day 1 to day 6. Blood samples for pharmacokinetic (PK) analysis, and safety parameters are collected before and after dosing according to the trial protocol.
Adults aged 18 ~ 75 years (inclusive), regardless of gender
Body weight ≥ 45.0 kg (female) or ≥ 50.0 kg (male), body mass index (BMI) in the range of 19 ~ 32 kg/m2 (inclusive);
Participants whose medical history, vital signs, physical examination, laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function, infectious disease screening, and other relevant tests), Chest X-ray, abdominal color Doppler ultrasound, electroencephalogram (EEG), alpha-fetoprotein (AFP), plasma ammonia, abnormal prothrombin, and other examination must be deemed suitable for participation in this study by the investigator;
Participants and their partners must use effective contraception (e.g., condoms, inert intrauterine devices, etc.) from 2 weeks prior to screening until 6 months after the end of the study, unless they have already undergone permanent sterilization procedures, such as bilateral tubal ligation or vasectomy; furthermore, they must not donate sperm or eggs.
Individuals with a history of allergies (allergic to two or more drugs, foods, or pollens);
Individuals with major psychiatric disorders, renal disease, neurological disorders, or other systemic diseases that the investigator deems may affect trial results;
Individuals with orthostatic hypotension (a decrease in systolic blood pressure of 20 mmHg or diastolic blood pressure of 10 mmHg upon standing compared to the supine position);
Participants with a 12-lead ECG QTcF>470 ms, or those with abnormal ECG findings that the study physician determines may influence the study results, or those with a history of severe arrhythmias, arrhythmia-related syncope, use of a cardiac pacemaker, or other cardiac-related conditions. Conditions include but are not limited to: heart failure; non-sustained or sustained ventricular tachycardia; sick sinus syndrome; or a family history of sudden death;
Single group
ammoxetine hydrochloride enteric-coated tablets
DrugOral administration; 20 mg
Area under the concentration vs. time curve for one dosing interval at steady-state (AUCtau,ss)
Maximum concentration observed during dosing interval at steady-state (Cmax,ss)
The incidence of adverse events (AEs)
Minimum concentration observed during dosing interval at steady-state (Cmin,ss)
Half-Life (t1/2)
Mean concentration observed during dosing interval at steady-state (Cav,ss)
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