Major depressive disorder
Conditions
Interventions
10mg/20mg/40mg/100mg/200mg:single dose
muti-doses:20/40/80mg,oral every day, 7days
Diet group :High fat diet
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) All subjects must participate in the consent process and sign the written informed consent; (2) Male and female; (3) Aged 18 to 45 years of age; (4) Body mass index (BMI) in the range of 18.0 to 26.0 kg/m2, body weight >= 50 kg for male,>=45 kg for female; (5) Normal or abnormal physical examination results without clinical significance; (6) Normal or abnormal results of vital signs examination without clinical significance; (7) The results of laboratory examination (routine blood, urine, liver function, renal function, blood glucose, electrolyte and coagulation function) are normal or abnormal without clinical significance; (8) Female pregnancy test is negative; (9) Serological tests (five items of hepatitis B, hepatitis C antibody, syphilis serum specific antibody, HIV antibody) were normal; (10) The results of 12 lead electrocardiogram were normal or approximately normal or abnormal without clinical significance; (11) The results of chest X-ray examination are normal or abnormal without clinical significance; (12) Normal or abnormal abdominal B-ultrasound examination results have no clinical significance; (13) The result of alcohol breath test is negative; (14) The results of urine nicotine test were negative; (15) Urine drug screening (morphine, methylamphetamine, ketamine, dimethyldimethoxyamphetamine, tetrahydrocannabinolic acid) was negative.
Exclusion criteria
Exclusion criteria: (1) Allergic constitution or history of drug or food allergy; (2) Any medical history that may affect the safety of the trial or the physiological disposition of the drug; (3) Any history of surgery or trauma that may affect the safety of the trial or the physiological disposition of the drug;; (4) Suffering from any unstable or recurrent disease, or disease that affects the physiological disposition of the drug; (5) A history of drug abuse/dependence in the past 2 years; (6) Have taken any drugs within 30 days before the trial; (7) Smoking within 2 weeks before medication, or during the trial; (8) Alcoholism [drinking more than 14 units per week in the first 3 months (1 unit alcohol ˜360mL of 5% beer, 45mL of 40% spirits or 150mL of 12% wine)], or drinking within 1 week before medication, or can't keep to prohibition against alcohol druing the trial; (10) Had blood loss or blood donation of 400mL or above within 90 days before the trial; (11) Faint of needle or blood phobia; (12) Lactating women; (13) Sperm or egg donation plan, birth plan, unwillingness or inability to take effective contraceptive measures within 30 days before the trial and six months after the trial; (14) The presence of neurological or mental disorders or language barriers that may prevent the successful completion of the study; (15) Due to other circumstances, the investigator considers tbe subject was inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood concentration;urine concentration; | — |
Countries
China
Contacts
Public ContactBai Nan
Chinese PLA General Hospital
Outcome results
None listed