MDD
Conditions
Interventions
Fasting group 1:T-R-R
Fasting group 2:R-T-R
Fasting group 3:R-R-T
Fed group 1:T-R-R
Fed group 2:R-T-R
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions; 2) to be able to complete the study in accordance with the requirements of the trial program; 3) Subjects (including subject partner) are willing to take no pregnancy plan within the next 6 months and voluntarily take effective contraceptive measures, see Appendix for specific contraceptive measures; 4) healthy subjects aged 20 to 65 years (including 20 and 65 years); 5) male subjects weighing no less than 50 kg, female subjects weighing no less than 45 kg. Body mass index (BMI) = body weight (kg)/height 2 (m2), body mass index in the range of 18 ~ 28kg/m2 (including the critical value); 6) health: no heart, liver, kidney, digestive tract, nervous system, mental disorders and metabolic abnormalities and other medical history; 7) physical examination, vital signs normal or abnormal no clinical significance.
Exclusion criteria
Exclusion criteria: 1. More than 5 cigarettes per day for the first 3 months of the trial; 2. allergic history of allergenic and allergy (a variety of drugs and food allergy) to paroxetine or their excipients; 3. History of drug and / or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, 25 mL of spirits, or 100 ml of wine); 4. Blood donation or extensive blood loss (> 450 mL) within three months before taking the study drug; 5. have difficulty swallowing or any history of gastrointestinal disease that affects the absorption of drugs; 6. suffer from any disease that increases the risk of hemorrhagic disease, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers; 7. Take any drug that changes liver enzyme activity 28 days before taking the study drug; 8. Take any prescription drugs, non-prescription drugs, any vitamin products, health care products or herbs within 14 days prior to taking the study drug; 9. inhibitors or inducers of the following CYP3A4, P-gp or Bcrp, such as itraconazole, ketoconazole or dronedarone; 10. 2 weeks before the test took a special diet (including dragon fruit, mango, grapefruit, and / or rich in xanthine diet, etc.) or strenuous exercise, or other effects of drug absorption, distribution, metabolism, excretion and other factors; 11. There have been significant changes in diet or exercise habits four weeks before the taking the study drugs; 12. took the research drug within three months before taking the study medication, or participated in the drug clinical trial; 13. ECG abnormalities have clinical significance; 14. Female subjects are in lactation or serum pregnancy outcomes during screening or during the trial; 15. Clinical laboratory examination has clinical significance; 16. hepatitis (including hepatitis B and hepatitis C), AIDS, syphilis screening positive; 17. Closed Angle glaucoma patients; 18. in the pre-study screening stage or before the study of acute disease; 19. Take up to chocolate, any caffeine-containing food or drink 48 hours before taking the study drug; 20. took any alcoholic products within 24 hours prior to taking the study; 21. alcohol and drug screening positive or drug abuse history over the past five years or 3 months before the trial; 22. Subjects who can not tolerate high-fat meals (2 boiled eggs 100g, 20g bacon, 1 butter toast 50g, 115g fried potato strips, 240ml whole milk) (this article only applies to participating meals Post-test subjects); 23. others.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration; | — |
Countries
China
Contacts
Public ContactYanhua Ding
The First Hospital of Jilin University
Outcome results
None listed