Evaluation of Bioequivalence and Food Effect of a New Strength Formulation of Ammoxetine hydrochloride Enteric-coated Tablets in Healthy Participants.The study is composed of 2 parts. Part 1 is a bioequivalence study with administration 1.5 hours after a high-fat meal, using a randomized, open-label, single-dose, four-period fully replicated design. Part 2 is a food effect study using a single-center, open-label, single-dose, two-period crossover design.
Adults aged 18 ~65 years (inclusive), male or female;
Body weight ≥ 45.0 kg (female) or ≥ 50.0 kg (male), body mass index (BMI) in the range of 19.0 ~ 28.0 kg/m2 (inclusive);
Participants with normal results or abnormal results without clinical significance in medical history, vital signs, physical examination, laboratory tests (including hematology, blood biochemistry, urinalysis, coagulation function, and related tests), chest X-ray, and other examinations.
Participants and their partners must use effective non-hormonal contraceptive measures (e.g., condoms, inert intrauterine devices, etc.) from 2 weeks before screening until 6 months after the end of the study, unless they have already undergone permanent sterilization (e.g., bilateral tubal ligation, vasectomy, etc.). Participants must also refrain from donating sperm or eggs;
Participants with a history of allergic constitution (allergic to two or more drugs, foods, or pollens);
Participants with psychiatric disorders, hepatic or renal dysfunction, gastrointestinal disorders, neurological disorders, or other systemic diseases;
Participants 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 QTcF interval exceeding the upper limit of normal (males >450 ms or females >470 ms) on 12-lead ECG, or clinically significant abnormalities on a ECG as judged by the investigator, or a history of arrhythmia, syncope associated with arrhythmia, use of a cardiac pacemaker, or other cardiac conditions. Note: Cardiac conditions include, but are not limited to: heart failure; hypokalemia; atrial fibrillation, atrial flutter, atrial premature beats, ventricular premature beats, non-sustained or sustained ventricular tachycardia; bradycardia or sick sinus syndrome; personal or family history of any cardiac conduction abnormalities; personal or family history of long QT syndrome (LQTS); or family history of sudden cardiac death;