Food-effect Study of Ammoxetine Hydrochloride Enteric-coated Tablets

Exclusion Criteria

• •1. Subjects with a history of allergies (allergic to two or more types of drugs, foods, or pollen);
• •2. Subjects suffering from psychiatric disorders, hepatic or renal diseases, gastrointestinal diseases, neurological diseases, or other systemic diseases;
• •3. Subjects with clinically significant abnormalities confirmed by comprehensive examinations including medical history, physical examination, electrocardiogram, and chest X-ray;
• •4. Subjects with systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg during the screening period;
• •5. Subjects with orthostatic hypotension;
• •6. Subjects with corrected QT interval (QTc) ≥ 450 ms (male) or ≥ 470 ms (female), or a history of prolonged QTc interval;
• •7. Subjects with a history of smoking or alcohol abuse (consumption of 14 units of alcohol per week within the 4 weeks prior to screening: 1 unit = 285 mL beer, or 25 mL spirits, or 150 mL wine; daily smoking ≥ 5 cigarettes) or other substance or drug abuse within the past year;
• •8. Subjects who have donated or lost more than 400 mL of blood within the 8 weeks prior to screening;
• •9. Subjects who have participated in other clinical trials within the 3 months prior to screening;
• •10. Subjects who habitually consume excessive amounts of caffeinated beverages or foods within the 4 weeks prior to screening, such as coffee, tea, chocolate, cola, or Red Bull (daily caffeine intake not exceeding 6 units). 1 caffeine unit = 1 cup of coffee (177.4 mL) = 2 cans of cola (354.9 mL) = 1 cup of tea (354.9 mL) = 1/2 cup of energy drink = 85 g chocolate;
• •11. Subjects who have used medications that alter the activity of liver enzymes (Cytochrome P450 2C19 and Cytochrome P450 3A4) within the 4 weeks prior to screening, such as dexamethasone, ketoconazole, rifampicin, omeprazole, or grapefruit
• •12. Subjects who have used prescription drugs, over-the-counter medications (except for occasional use of acetaminophen and nasal sprays), herbal remedies, vitamins, or minerals within the 2 weeks prior to screening, or for whom the washout period of prior medications (based on the longest half-life) is less than 5 half-lives before screening;
• •13. Subjects using any psychiatric medications or psychoactive substances;
• •14. Pregnant or lactating women, or female subjects with a positive pregnancy test during the screening period;
• •15. Subjects who have already participated in this trial;
• •16. Subjects considered by the investigator to have any factors that make them unsuitable for participation in this trial.