depression
Conditions
Sponsors
The First Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Signed the informed consent before the test, and fully understood the test content, process and possible adverse reactions; 2. Able to complete the research according to the requirements of the test plan; 3. Subjects had no birth plan from 14 days before self-medication to 6 months after the end of the study and voluntarily adopted effective and appropriate contraceptive measures; 4. Male and female subjects aged from 18 to 45 years; 5. The weight of male subjects should not be less than 50 kg, and that of female subjects should not be less than 45 kg, with a BMI of 19.0-26.0 kg/m2; 6. No history of cardiac, hepatic, renal, gastrointestinal, neurological, psychiatric abnormalities or metabolic abnormalities.
Exclusion criteria
Exclusion criteria: 1. Those who had an average daily smoking quantity >= 5 cigarettes within 3 months prior to screening and could not quit smoking during the test; 2. Allergic constitution, or allergic to the drug components and their analogues; 3. A history of alcohol abuse; 4. Blood donation or large blood loss within 3 months before taking the study drug; 5. A history of dysphagia or any gastrointestinal illness that affects drug absorption; 6. A history of glaucoma or glaucoma; 7. Have a history of urinary retention; 8. A history of hyperthyroidism or hyperthyroidism; 9. Used any prescription drugs within 14 days prior to taking the study drug; 10. Use of any over-the-counter medicine, Chinese herbal medicine or health care product within 7 days prior to taking the study drug; 11. Had taken a special diet (such as grapefruit) or had strenuous exercise, or had other factors affecting drug absorption, distribution, metabolism, excretion, etc., within 7 days before taking the study drug; 12. Participated in clinical trials of other drugs or devices within 3 months prior to taking the study drug; 13. Abnormalities deemed clinically significant by the clinician, including physical examination, vital signs examination, electrocardiogram or clinical laboratory examination; 14. Hepatitis B surface antigen positive, hepatitis C antibody positive, HIV antibody positive or syphilis screening positive; 15. Consuming chocolate, any food or drink containing caffeine or rich in xanthine within 48 hours before taking the study drug; 16. Have taken any alcoholic product or been screened for positive alcohol within 24 hours prior to taking the study drug; 17. Persons who are screened positive for drug abuse or have a history of drug abuse in the past five years or have used drugs in the three months prior to the test; 18. Female subjects are lactating or have positive pregnancy test results during the screening period or during the test; 19. Patients who cannot tolerate venipuncture and have a history of needle sickness and blood sickness; 20. Patients with a history of hospitalization or surgery within 3 months prior to screening (except appendicitis); 21. Lactose intolerant; 22. Those who have special requirements on diet and cannot follow the uniform diet; 23. Subjects who cannot participate in the test due to their own reasons; 24. Other investigators determine unsuitable subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactLiu Jian
The First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed