difficulty falling asleep and/or maintaining sleep
Conditions
Interventions
B:YZJ-1139 tablets mimetic agent (1 tablet)
Escitalopram oxalate citalopram 10 mg (1 tablet)
A:YZJ-1139 tablets 40mg(1 tablet)
Escitalopram oxalate citalopram 10 mg(1 tablet)
Sponsors
Second Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Healthy subjects aged 18-45 years (including the critical value), both male and female; 2) Male weight =50.0kg, female weight =45.0kg; Body mass index (BMI) in the range of 19.0~26.0kg/m2 (including the critical value); 3) Physical examination, vital signs, 12-lead electrocardiogram, laboratory examination is normal or abnormal without clinical significance; 4) Good health, no respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system and other serious diseases or chronic disease history; 5) Fertile subjects (including partners) have no plans to have children or donate sperm/eggs from 2 weeks before screening to 3 months after the last dose, and voluntarily use appropriate contraceptive methods; 6) Subjects who can understand and are willing to strictly follow the clinical trial protocol to complete this trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) People with allergies: people with a history of two or more drug or food allergies; Or known allergy to experimental drugs and excipients; 2) People who have difficulty swallowing tablets, have special dietary requirements, and cannot accept a unified diet; 3) Difficulty in venous blood collection, inability to tolerate venipunction, and history of needle fainting and blood fainting; 4) Patients who had surgery within 30 days prior to screening, or who planned to have surgery during the trial; 5) Past or current history of narcolepsy, obstructive sleep apnea, history of complex sleep behavior (such as sleepwalking, dream-driving, etc.), history of severe unconscious hypoglycemia, history of stroke, epilepsy and other psychosis (such as anxiety, depression, etc.), history of convulsive disease, cataplexy; 6) Known suffered congenital long QT or QT syndrome or screening phase of ecg examination male QTcF > 450 ms, women QTcF > 470 ms (QTcF = QT/(RR ^ 0.33)); 7) Hepatitis b virus surface antigen, hepatitis c virus antibody, syphilis helicoid specificity antibodies, the human immunodeficiency virus (HIV) any anomalies have clinical significance; 8) Those with a history of drug abuse or drug use within 6 months before screening or with positive urine drug screening results; 9) Within 3 months prior to screening often drinkers, that drinking more than 14 units of alcohol a week (1 unit of material amount 45 mL 360 mL beer or alcohol liquor with 40% or 150 mL wine) or trial cannot stop using any alcohol products, Or alcohol breath test result greater than 0.0mg/100mL; 10) Donors or massive blood loss (>400 mL) within 3 months before screening, receiving blood transfusion or use of blood products, or planning to donate blood during or within 1 month after the trial; 11) Excessive consumption of tea, coffee and/or caffeinated beverages (> 8 cups, 1 cup ˜250 mL) per day in the previous 3 months; 12) Smokers =5 cigarettes per day in the 3 months before screening or unable to stop using tobacco products during the study; 13) Participated in any clinical trial and used a drug or medical device within 3 months before screening or planned to participate in another clinical trial during the trial; 14) Screening received within 30 days before vaccination, or plan vaccination during test; 15) Use of any drugs (e.g., inducters-barbiturates, carbamazepine, phenytoin, glucocorticoids, or omeprazole) that inhibit or induce hepatic response to drugs within 30 days before admission; Inhibitors - SSRI antidepressants, cimetidine, diltiazem, large ring lactone class, nitro imidazoles, sedative hypnotics, verapamil, fluoroquinolone, antihistamines class); 16) Within 14 days before using any prescription drugs, over-the-counter drugs, health care products, vitamin, Chinese herbal medicine; 17) Within 14 days before eat grapefruit and grapefruit, dragon fruit, mango metabolic enzymes water fruit or related products; 18) Intake of caffeinated or xanthine-rich beverages or foods (such as coffee, strong tea, chocolate, coke, etc.) within 48 h before admission; 19) Female subjects in lactation or pregnancy outcomes was; 20) From the screening stage to give medicine acute disease; 21) The researchers think that the person should not be included in.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety outcome;PK outcome;PD outcome; | — |
Countries
China
Contacts
Public ContactZhihong Xie
Second Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed