Insomnia
Conditions
Interventions
Group 1:T1-T2-R
Group 2:T2-R-T1
Group 3:R-T1-T2
Sponsors
Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who sign informed consent before the trial and fully understand the content, process and possible adverse reactions of the test; 2. The research objects can be completed according to the requirements of the test scheme; 3. Those who have no family planning and voluntarily take effective contraceptive measures (including partners) within 6 months after the last drug administration; 4. Healthy subjects aged 18-55 (including 18 and 55 years old); 5. The weight of male subjects is not less than 50kg, and that of female subjects is not less than 45kg. Body mass index (BMI) = body weight (kg) / height 2 (M2), with body mass index (BMI) ranging from 18 to 28 kg / m2 (including the critical value); 6. Subjects with normal or abnormal physical examination and vital signs without clinical significance.
Exclusion criteria
Exclusion criteria: 1. Subjects who smoked more than 5 cigarettes a day 3 months before the trial; 2. Subjects with a history of drug abuse and / or alcoholism (14 units of alcohol per week: 1 unit = 285 ml beer, 25 ml spirits, or 100 ml wine); 3. Those who have history of drug abuse or used drugs in the past five years; 4. Subjects of allergic constitution (allergy to various drugs and foods); 5. Those who donated blood or lost a lot of blood (> 450 ml) within three months before screening; 6. Subjects who took any drugs to change the activity of liver enzymes 28 days before screening; 7. Subjects who have taken any prescription drug, over-the-counter drug, any vitamin product or herbal medicine within 14 days before screening; 8. Those who have taken special diet (including pitaya, mango, grapefruit, etc.) within 14 days before screening, or have strenuous exercise, or other factors affecting drug absorption, distribution, metabolism and excretion; 9. Subjects with dysphagia or any history of gastrointestinal diseases that affect drug absorption; 10. For patients with respiratory dysfunction (such as obstructive sleep apnea and chronic obstructive pulmonary disease); 11. Subjects of sleep paralysis, hypnotic / semi awake hallucinations, and cataplexy like symptoms; 12. Subjects with clinically significant abnormalities in clinical laboratory examination or other clinical findings within 12 months before screening (including but not limited to gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular diseases, such as depression with suicidal tendency); 13. 12 lead ECG abnormal subjects with clinical significance; 14. Patients with viral hepatitis (including hepatitis B and hepatitis C), human immunodeficiency virus antibody and Treponema pallidum specific antibody were screened positive; 15. Female subjects were in lactation or serum pregnancy during the screening period or the test process, and the results were positive; 16. Patients with acute disease or concomitant medication from screening stage to study medication; 17. Ingestion of chocolate, any caffeinated or xanthine rich food or drink 24 hours prior to administration of the study drug; 18. Subjects who had taken any alcoholic products within 24 hours prior to administration of the study medication; 19. Subjects with positive urine screening within 24 hours before administration of the study medication; 20. Subjects who have taken the study drug or participated in the drug clinical trial within three months before taking the study drug; 21. Subjects with other factors not suitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics;safety; | — |
Countries
China
Contacts
Public ContactTaotao Jiang
Shanghai Haiyan Medical Technology Co., LTD
Outcome results
None listed