It is intended to be used for insomnia and depression with insomnia.
Conditions
Interventions
Group 5mg:Administration
Group 10mg:Administration
Group 20mg:Administration
placebo group:Administration
Group 80mg:Administration
Group 40mg:Administration
Group 60mg:Administration
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male/female subjects aged 18 to 45 years old (including end value) at the time of signing the informed consent; 2. The body mass index (BMI) at screening is between 18.5 and 28.0 kg/m^2 (including the end value), and the weight of male subjects is not less than 50 kg, and the weight of female subjects is not less than 45 kg; 3. Those who voluntarily participate in and sign the informed consent form after understanding the purpose, content, process and possible risks of the trial. 4. Able to communicate well with the investigator, willing and able to comply with the lifestyle restrictions specified in the protocol, and cooperate with the completion of the trial process.
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of present or past medical conditions with the following diseases or functional disorders that the investigator judges may have an impact on clinical research, including but not limited to central nervous system (such as narcolepsy, etc.), cardiovascular system, respiratory system (such as abnormal anatomical structure of the airway, such as congenital micro-tongue, mandibular dysplasia, modified Mallampati score grade III.-IV., etc.); chronic obstructive pulmonary disease or sleep apnea syndrome), digestive system, urinary system, endocrine system, blood system and other diseases; 2. Presence of any surgical condition or condition that may significantly affect the absorption, distribution, metabolism, and excretion of the drug, or any surgical condition or condition that may pose a hazard to the subjects enrolled in the trial; Such as a history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, bowel resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, peptic ulcer, gastrointestinal bleeding, etc.; 3. Those who have current or previous mental disorders and brain dysfunctions; 4. According to the Columbia Suicide Severity Rating Scale (C-SSRS), the subject is at risk of suicide or has a risk of suicide according to the clinical judgement of the investigator, or has a history of self-injurious behaviour; 5. Those who have a history of surgery within 3 months before administration, or have not recovered from surgery, or have an expected surgical plan during the trial; 6. Those who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or food supplements (including vitamins, health foods, etc.) within 2 weeks or 5 half-lives of the drug (whichever is longer) before administration. 7. Those who are known to be allergic to any of the ingredients in the investigational drug; People with allergies (two or more drug and food allergies); 8. Those with abnormal ECG indicators and clinically significant as judged by the investigator (such as QTcF interval: 450 ms > for males or 470 ms > for females); 9. Abnormal vital signs or pulse oximetry (SpO2) (such as resting pulse rate 100 beats/min; systolic blood pressure = 140 mmHg; diastolic blood pressure = 90 mmHg; pulse oximetry less than 95%), and judged by the investigator to be clinically significant. 10. Those who have abnormal physical examination, chest X-ray (anterior) and abdominal B-ultrasound examination and are judged to be clinically significant by the investigator. 11. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (Cr) exceeding the upper limit of normal by 1.5 times, or other abnormal laboratory indicators that are judged to be clinically significant by the investigator. 12. Those who are not negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), and Treponema pallidum antibody (TP-Ab); 13. Those who have a history of drug or drug abuse within 1 year before screening, or those who have a positive urine drug screen; 14. Those who have a history of alcohol abuse within 1 year before screening (i.e., drinking more than 14 standard units per week, 1 unit = 360 mL of beer or 45 mL of spirits with 40% alcohol or 150 mL of wine) or positive alcohol breath test. 15. The average daily smoking volume>= 5 cigarettes in the 3 months before screening, or those who
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stanford Sleepiness Scale (SSS) assessment;Vital signs;electrocardiogram;Holter ECG; | — |
Secondary
| Measure | Time frame |
|---|---|
| physical examination;pharmacokinetics; | — |
Countries
China
Contacts
Public ContactGuoping Yang
The Third Xiangya Hospital Central South University
Outcome results
None listed