Adult depression
Conditions
Interventions
Fast:T
Fast:R
Fed:T
Fed:R
Sponsors
Changsha Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Chinese volunteers aged 18 years and older (including 18 years old), both men and women; 2. The male subject has a body weight of not less than 50 kg, the female subject has a body weight of not less than 45 kg, and the body mass index ranges from 19.0 to 26.0 kg/m 2 (including the critical value). Body mass index (BMI) = weight (kg) / height 2 (m2); 3. Sign the informed consent form before the trial and fully understand the test content, process and possible adverse reactions; 4. Be able to communicate well with the researcher and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. (screening/check-in) Those who participated in any drug clinical trial and used research drugs within 3 months prior to the trial; 2. (screening/check-in) for respiratory, cardiovascular, endocrine, nervous system, hematology, immunology (including hereditary immunodeficiency in individual or family history), metabolic abnormalities, lymphoproliferative disorders, skin (A major medical history including rash, pruritus, and urticaria, and the researchers believe that there is still clinical significance; 3. (screening/check-in) (screening/check-in) with epilepsy, mania/light mania, serotonin syndrome (SS) or neuroleptic malignant syndrome (NMS) history or other psychiatric history And the researchers believe that there are still clinical significance; 4. (screening/check-in) with any disease that increases the risk of bleeding, such as active acne, acute gastritis or gastric and duodenal ulcers, and the researchers believe that there is still clinical significance; 5. (screening consultation) Those who have a history of allergies to fluoxetine hydrobromide tablets or any of the ingredients in the prescription, have two or more food or other substance allergies; 6. (screening consultation) can not tolerate venous sputum or have a history of halo, fainting; 7. (Screening/Check-in) Within 6 months prior to the trial, the operator who has been judged by the investigator to affect the absorption, distribution, metabolism, or excretion of the drug; or has undergone surgery within 4 weeks before the trial; or is planning to study Surgery during the period; 8. (screening/check-in) Those who have taken any drug within 14 days before the test (including Chinese herbal medicines and health care products); 9. (screening consultation) Any drug that affects CYP2D6 enzyme, CYP3A4 enzyme and CYPC9 enzyme activity within 30 days before the test, reversible, selective MAOA inhibitor (eg, moclobemide), irreversible, selective MAOB inhibition Agents (Selegiline, rasagiline), anti-depressants with serotonergic effects and herbs containing St. John's wort (P. sylvestris), bupropion, potent CYP3A4 inhibitors (eg Itracon Oxazole, voriconazole, clarithromycin, telithromycin, nefazodone, cognavatan and many HV protease inhibitors) and CYP2C9 inhibitors (such as fluconazole and amiodarone); 10. (Screening/Check-in) Blood donors or a large number of blood loss (>450 ml) within 3 months prior to the trial; 11. (screening/check-in) drug abusers or soft drugs (eg marijuana) 3 months before the test or hard drugs (eg cocaine, phencyclidine, etc.) 1 year before the test; 12. (screening/check-in) smokers or more than 5 cigarettes per day for the first 3 months of the trial, or can not stop using any tobacco products during the trial; 13. (screening/check-in) Alcoholics or regular drinkers within 6 months prior to the test, ie drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150% alcohol) mL wine); or unwilling to stop drinking alcohol or any alcohol-containing product during the trial; 14. (screening/check-in) Drinking excessive amounts of tea, coffee and/or caffeinated beverages (8 cups or more, 1 cup = 250 mL) per day, or disagreeing to stop taking caffeinated foods or beverages during the trial period (such as coffee, tea, chocolate, etc.); 15. (Screening/Check-in) Eating foods that may affect the metabolism of the drug within 48 hours before administration (including grapefruit or grapefruit products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactLi Xin
Changsha Third Hospital
Outcome results
None listed