insomnia
Conditions
Interventions
Test group :YZJ-1139 20mg, D1
Ticagrelor 90mg, D2~D7, BID
YZJ-1139 20mg + ticagrelor 90mg, D6
Sponsors
shulan(hangzhou)hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Subjects who are able to understand and are willing to strictly follow the clinical trial protocol to complete this trial and sign the informed consent form; 2) Male and female subjects aged 18~45 years (including cut-off value); 3) Male weight = 50.0kg, female weight = 45.0kg, body mass index (BMI) within the range of 19.0~26.0kg/m^2 (including the cut-off value); 4) normal or abnormal physical examination, vital signs, 12-lead ECG, laboratory tests are not clinically significant; 5) Good health, no respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, psychiatric system Those with a history of serious and chronic diseases; 6) Subjects (including partners) have no fertility plan, sperm/egg donation plan and voluntarily use adequate contraception within 3 months from signing informed consent to the last dose.
Exclusion criteria
Exclusion criteria: 1) Allergies: Those with a history of two or more drug or food allergies in the past; or those who are known to be allergic to YZJ-1139 tablets and test concomitant drugs and excipients; 2) Those who have difficulty swallowing tablets, or those who have special dietary requirements and cannot accept the standard diet provided by the research center; 3) Those who cannot tolerate venipuncture, and those who have a history of fainting and blood sickness; 4) Those who have a history of narcolepsy, obstructive sleep apnea, complex sleep behaviors (such as sleepwalking, dream driving, etc.), severe unconscious hypoglycemia, stroke, epilepsy and other psychiatric neurological diseases (including anxiety, depression, etc.), convulsive diseases, cataplexy; 5) Those with bleeding tendency (such as recent trauma, recent surgery, coagulation dysfunction, active or recent intestinal bleeding), active pathological bleeding, intracranial hemorrhage, or other diseases that can change or increase bleeding tendency (peptic ulcer, Henoch-Schonlein purpura, lupus erythematosus, etc.); 6) Patients with clinical significance in the determination of hepatitis B surface antigen, hepatitis C virus antibody, hepatitis C virus core antigen, human immunodeficiency virus (HIV) antigen antibody combined detection, and treponema pallidum specific antibody determination; 7) Regular drinkers within 6 months prior to screening, i.e., drinking an average of more than 14 units of alcohol per week (1 unit ˜ 360mL of beer or 45mL of spirits with 40% alcohol or 150mL of wine) or > alcohol breath test results during the screening period0mg/100mL; 8) Those who have used soft drugs (such as marijuana) within 3 months before screening or taken hard drugs (such as cocaine, amphetamines, phencyclidine and piperidine) within 1 year before screening; or those with a history of substance abuse; or those who have a positive drug abuse screen at screening; 9) Those who have smoked =5 cigarettes per day within 3 months before screening or cannot stop using any tobacco products during the trial; 10) Those who have donated blood or lost a large amount of blood (> 400mL) within 3 months prior to screening, received blood transfusion or used blood products; 11) Those who have participated in any clinical trial and been given investigational drugs or investigational medical devices within 3 months prior to screening; or those who plan to participate in other clinical trials during the study period; 12) Those who have undergone surgical procedures within 30 days prior to screening, or who plan to undergo surgical procedures during the study; 13) Received vaccination within 30 days prior to screening, or planned vaccination during the trial; 14) Use of any drug that inhibits or induces hepatic metabolism of the drug within 28 days prior to screening (e.g.: inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; Inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); 15) Those who have taken any prescription drugs, over-the-counter drugs, health products, vitamins, or Chinese herbal medicines within 14 days before screening; 16) Consumption of grapefruit, grapefruit, dragon fruit, mango and other fruits or related products that affect metabolic enzymes within 7 days before screening; 17) Intake of caffeine- or xanthine-rich beverages or foods (such as coffee, strong tea, chocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-t, AUC0-8, Tmax, t1/2z, CLz/F, Vz/F, etc. of YZJ-1139; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, serious adverse events, laboratory tests (blood routine, blood biochemistry, urinalysis, coagulation function), vital signs, 12-lead ECG and physical examination urinalysis routine, coagulation function), vital signs, 12-lead ECG, and physical examination findings; | — |
Countries
China
Contacts
Public ContactChen Guiling
shulan(hangzhou)hospital
Outcome results
None listed