Treatment of insomnia characterized by difficulty falling asleep/sleep maintenance disorders
Conditions
Interventions
Pre-test group :The first cycle: YZJ-1139 tablets, 1 tablet each time, taken on an empty stomach, single dose
Cleaning period of 3 days
Second cycle: YZJ-1139 tablets, 1 tablet each time, in high-fat postprandial state, single dose
Pre-test group :The first cycle: YZJ-1139 tablets, 1 tablet each time, in high-fat postprandial state, single dose
The second cycle: YZJ-1139 tablets, 1 tablet each time, taken on an empty stomach, single dose
Formal test group :The first cycle: YZJ-1139 tablets, 1 tablet each time, taken on an empty stomach, single dose
Formal test group :The first cycle: YZJ-1139 tablets, 1 tablet each time, in high-fat postprandial state, single dose
Sponsors
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who can understand and are willing to strictly abide by the clinical trial protocol to complete the trial and sign the informed consent; 2. Healthy subjects, males and females between 18 and 45 years old (including the cut-off value), with an appropriate sex ratio; 3. Male weight =50.0kg, female weight =45.0kg; body mass index (BMI) is in the range of 19.0~26.0kg/m2 (including cut-off value); 4. Subjects (including partners) shall ensure that they have no plans to fertility or donate sperm/eggs within 2 weeks before the screening to 6 months after the last dose, and voluntarily take appropriate contraceptive measures, and voluntarily take non-drug contraceptive measures during the trial period.
Exclusion criteria
Exclusion criteria: 1. People who are known to be allergic to YZJ-1139 tablets or its excipients, or have a history of specific allergies (asthma, measles, eczema, etc.), or allergic constitution (such as those who are allergic to two or more drugs, foods, such as milk and pollen), or have a history of food, drug allergy or allergic reaction judged by other researchers to be clinically significant; 2. Have a history of tablet dysphagia or any gastrointestinal disease affecting drug absorption; 3. Those who are lactose intolerant (those who have had milk diarrhea) or have special requirements for diet (such as vegetarians) and cannot accept and follow the unified diet; 4. Those who have difficulty in venous blood collection, can not tolerate venous puncture, or have a history of needle and blood sickness; 5. The results of vital signs (sitting blood pressure, pulse and temperature), physical examination, laboratory examination (blood routine examination, urine routine examination, blood biochemistry, blood coagulation function, thyroid function), 12 lead ECG, and chest X-ray (lung CT examination can be adjusted according to the epidemic situation), which are judged by the researcher to be clinically significant; 6. Any abnormality of hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), treponema pallidum specific antibody (TP Ab) and human immunodeficiency virus antibody (HIV Ab) has clinical significance; 7. Diseases of heart, liver, lung, kidney, digestive tract, blood system, neuropsychiatric system, etc. judged by the researcher as clinically significant, including anxiety, depression, severe infection, trauma or major surgery; 8. Those who frequently drink alcohol within 6 months before screening, that is, the average weekly alcohol consumption is = 14 units (1 unit alcohol ˜ 360mL beer or 45mL spirits or 150mL wine with 40% alcohol); 9. Smoking = 5 cigarettes per day within 3 months before screening; 10. Those who drink excessive tea, coffee and/or caffeinated drinks (more than 8 cups, 1 cup=250mL) every day within 3 months before screening; 11. Those who have undergone surgery within 3 months before screening, or who plan to undergo surgery during the study period, and those who have undergone surgery that will affect drug absorption, distribution, metabolism and excretion; 12. Those who participated in any clinical trial 3 months before screening; 13. Those who donate blood or lose a lot of blood (= 400mL) within 3 months before screening, or receive blood transfusion or use blood products; 14. Those who have used any drugs that inhibit or induce liver metabolism of drugs (such as inducers - barbiturates, carbamazepine, phenytoin, rifampicin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, ketoconazole, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines, ritonavir) within 28 days before screening; 15. Those who have used the vaccine for less than one month before taking the drugs for clinical trials for the first time (less than one month after the injection of COVID-19 vector vaccine, less than two weeks after the injection of inactivated and recombinant protein vaccine); 16. Those who have used any prescription drugs and Chinese herbal medicine within 28 days before administration, and used over-the-counter drugs or food supplements (such as vitamins and calcium supplements) within 14 days; 17. Those who have eaten grapefruit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8;Tmax;t1/2; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, serious adverse events, laboratory tests (blood routine, blood biochemistry, urine routine, coagulation, thyroid function), vital signs, 12-lead electrocardiogram, and physical examination results; | — |
Countries
China
Contacts
Public ContactWeniping Wang
Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
Outcome results
None listed