insomnia
Conditions
Interventions
AB group:phase I: oral at fasting state
phase II: oral after meal
BA group:phase I: oral after meal
phase II: oral at fasting state
Sponsors
Shanghai Xuhui District Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Healthy subjects; 2) Aged between 18 and 45 years (including 18 and 45); 3) Body mass index (BMI) is between 19 and 26 (including 19 and 26). BMI = weight (kg)/ height2(m2), the body weight of the subject at the time of entry into the study must be >= 45.0kg female and >= 50.0kg male; 4) Physical examination (vital signs, height, weight, chest and abdomen, etc.) and laboratory examination (blood routine, blood biochemical, urine routine), virological examination, 12-lead electrocardiogram. No abnormality or abnormality in chest radiograph (posterior and anterior) examination but no clinical significance; 5) Subjects (including male subjects) shall guarantee from 2 weeks before screening to 3 months after the last administration. There is no pregnancy plan and no voluntary effective contraceptive measures, and there is no sperm or egg donation plan, and non-drug contraceptives should be used voluntarily during the trial period; 6) Able to understand the procedures and methods of this study, willing to complete this study in strict compliance with the clinical trial protocol, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) The presence of heart, liver, lung, kidney, digestive tract, blood system, neurological or neuropsychiatric disorders of clinical significance was determined by the investigator, including anxiety and depression disorders, severe infections, Traumatic or major surgical operation; 2) A history of food or drug allergy or allergy determined to be clinically significant by the researcher; 3) A history of dysphagia or any gastrointestinal disease that interferes with drug absorption; 4) Screening for persons with a history of drug abuse in the first 6 months or positive screening for drug abuse during the study period; 5) Screening those who have undergone surgery in the previous 3 months, or plan to undergo surgery during the study period, and those who have undergone surgery that may affect the absorption, distribution, metabolism and excretion of drugs; 6) Screening those who have participated in any drug clinical trial as subjects within the first 3 months; 7) Screening blood donation or blood loss >=400mL in the first 3 months, or receiving blood transfusion or blood products >= 400 ml; 8) Screening for smokers who had smoked more than 5 cigarettes per day in the previous 3 months or were unable to quit as required during the study period; 9) Screening for a history of alcohol abuse in the previous 3 months (14 or more units per week: 1 unit = 360mL beer, 45mL spirits with 40% alcohol, or about 150mL wine), or if the breath test is positive for alcohol; 10) Screen for excessive tea, coffee, and/or caffeine-rich beverages per day for the first 3 months (8 cups above, 1 cup =250mL); 11) Screen for any prescription drugs and Chinese herbs used within 1 month prior to screening, and non-prescription drugs, medical or food supplements used within 2 weeks, such as vitamins and calcium supplements; 12) Screening for any drug that had been used in the previous month to change the liver drug enzyme activity (e.g., inducer - babitumates, carbamazepine, phenytoin, rifampin, glucocorticoids, omeprazole; The antimicrobial agents - SSRI antidepressants, ketoconazole, cimetidine, Diltiazem, macrolide nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines class, Ritonavir); 13) Study alcohol consumption, consumption of xanthine or caffeine-rich foods and beverages (including tea, chocolate, coffee, cola, etc.), consumption of grapefruit, lime, etc., or preparation of such foods and beverages 3 days prior to administration) or cannot be avoided within 24 hours before and during the study period above food and beverage, tobacco, alcohol, or avoid other influence drug absorption, distribution, metabolize, excretion and other factors; 14) Lactose intolerant (has had diarrhea from drinking milk) or has special dietary requirements (e.g vegetarians), or people who can't follow a uniform diet; 15) Virologic examination (Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (HCV-AB), there was a positive junction with the human immunodeficiency virus antibody (HIV-AB) and treponema pallidum antibody (TREponema pallidum) results; 16) Pregnant or lactating women, or pregnancy tests are positive; 17) Patients who cannot tolerate venipuncture and have a history of fainting needles and blood; 18) The investigator considers any subject unfit to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (Cmax, AUC0-t, AUC0-8, Tmax, t1/2);Adverse events; | — |
Countries
China
Contacts
Public ContactTaotao Jiang
Shanghai Haiyan Medical Technology Co., LTD
Outcome results
None listed