Insomnia characterized by difficulty falling asleep/sleep maintenance
Conditions
Interventions
Experimental group:YZJ-1139 Tablets + Midazolam Oral Solution
Sponsors
Huazhong University of Science Tongji Hospital, Tongji Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Chinese healthy subjects, no gender limit; 2. Aged 18 to 65 years (including the threshold); 3. Weight: male >= 50.0kg, female >= 45.0kg, BMI: between 19.0 and 26.0 kg/m^2 (including the boundary value); 4. Understand and sign the informed consent to participate in this study voluntarily.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to test drugs (including YZJ-1139, midazolam), benzodiazepines or their components, or have a history of other drugs, food allergies or allergic reactions; 2. Those who have difficulty swallowing; 3. Those who have a history of dizziness and bleeding, difficulty in venipuncture or who cannot tolerate venipuncture; 4. Those who have special requirements for diet and cannot comply with the unified diet; 5. Those who have a history of diseases such as the heart, liver, lung, kidney, digestive tract, blood system, neuropsychiatric system, etc., including anxiety, depression, etc., and who are judged by the investigator to be clinically significant; 6. Vital signs and physical examination, laboratory examination, 12-lead electrocardiogram, chest X-ray, abdominal B-ultrasound and other abnormalities with clinical significance; 7. Serological tests (hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), Treponema pallidum specific antibody (AntiTP)) with one or more positive results; 8. Have a history of drug abuse, or one or more positive results of urine illicit drug screening (morphine, tetrahydrocannabinol acid, methamphetamine, MDMA, ketamine) during the screening period; 9. Those who use hypnotic drugs frequently (> 1 time per month), or have a positive screening result for benzodiazepine urine drugs during the screening period; 10. Those who have undergone surgery within 3 months before or during screening, or who have undergone surgery that affects drug absorption, distribution, metabolism, and excretion, or who plan to undergo surgery during the study; 11. Frequent drinkers within 3 months before screening, that is, drinking more than 14 units of alcohol per week (1 unit is approximately equal to 360mL of beer or 45mL of spirits with an alcohol content of 40% or 150mL of wine) or those who cannot stop using any alcohol products during the test, or those who have an alcohol breath test result greater than 0.0mg/100mL; 12. Those who smoked more than 5 cigarettes per day within 3 months before screening, or those who could not stop using any tobacco products during the test, or those who were positive for nicotine screening; 13. Those who drink too much tea, coffee or caffeine-rich beverages (more than 8 cups, 1 cup = 250 mL) every day within 3 months before screening; 14. Those who donated blood or lost a large amount of blood >=400mL within 3 months before screening, received blood transfusion or used blood products, or planned to donate blood during the trial; 15. Those who have participated in any drug clinical trials within 3 months before screening; 16. Those who have used any drugs that inhibit or induce the activity of liver drug enzyme CYP3A4 within 28 days before screening (such as: inducers - barbiturates, carbamazepine, rifampicin, phenytoin, glucocorticoids, St. John's wort, etc.; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); 17. Those who have been vaccinated within 28 days before screening or who plan to be vaccinated during the trial; 18. Those who have taken any medicines, Chinese herbal medicines, over-the-counter medicines or food supplements such as vitamins and calcium supplements within 14 days before the first administration; 19. From screening to D-1 check-in, have eaten grapefruit, grapefruit, lime, star
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters;Adverse event; | — |
Countries
China
Contacts
Public ContactLiu Dong, Ren Xiuhua
Outcome results
None listed