Insomnia characterized by difficulty falling asleep/sleep maintenance disorder
Conditions
Interventions
test group:Single oral administration
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1) Gender: Male healthy subjects who have no birth plan during the study and within 1 year after the end of the study, And take effective contraceptive measures with both of their sexual partners; 2) Age: The age at the time of signing the informed consent form is 18-50 years old (including the cut-off value), and the ages of the same batch are the same not more than 10 years old; 3) Weight: greater than 50.0kg, subject's body mass index (BMI) is between 19.0~26.0kg/m2 (including boundary value); 4) Subjects must give informed consent to this study before the experiment, and voluntarily sign a written informed consent form; 5) The subject has good hygiene habits, can communicate well with the researcher and can follow the research The study is required to be completed.
Exclusion criteria
Exclusion criteria: 1. Comprehensive physical examination, laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function, thyroid function (FT3, FT4, TSH)), fecal occult blood, 12-lead electrocardiogram, X-chest radiograph (positive position), belly; Those with abnormal B-ultrasound (hepatobiliary, pancreas, spleen and kidney) examinations and clinical significance; 2. Those who are positive for any of hepatitis B surface antigen or e antigen, hepatitis C virus antibody IgG, HIV antigen/antibody, and Treponema pallidum antibody; 3. Have taken any clinical trial drugs or participated in any drug clinical trials within 3 months before the screening period; 4. Any drugs that alter liver enzyme activity were used within 4 weeks before screening (see Appendix 1). 5. Those who have received any hypnotics, antidepressants, antipsychotics, anticholinergics, and memory-enhancing drugs within 4 weeks before taking the medicine; 6. Any prescription drugs or over-the-counter drugs, any vitamin products, health medicines or Chinese herbal medicines were used in the 14 days before screening; 7. People with memory loss and abnormal behavior in the past; 8. Those with a history of drug dependence in the 2 years before screening; 9. Cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Heart failure above NYHA 2; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmia needs treatment or intervention; (5) QTcF > 450 ms (male) during the screening period; 10. Those who have undergone major surgery within 6 months before the screening period or the surgical incisions are not completely healed; major operations include but are not limited to anyone who has a significant risk of bleeding, prolongs the period of general anesthesia, or has an open biopsy or obvious traumatic injury 11. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before screening; 12. Hemorrhoids or perianal diseases accompanied by regular/current blood in the stool; those with gastrointestinal dysfunction such as irritable bowel syndrome and inflammatory bowel disease, which may affect drug absorption by the researcher's judgment; 13. People with allergies, including those with a history of severe drug allergies or drug allergies, and those who are known to be allergic to this product or similar drugs and excipients; any food ingredients are allergic or have special dietary requirements, and cannot follow a unified diet; 14. Any clinical history of serious diseases or diseases or conditions that the investigator thinks may affect the test results (such as: history of obstructive sleep apnea, history of severe unconscious hypoglycemia, history of stroke, chronic epilepsy or neurological disorders, etc. History of convulsive diseases, cataplexy, etc.), including but not limited to history of circulatory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, mental and metabolic diseases; 15. Habitual constipation or diarrhea; 16. Alcoholism or regular drinking in the 6 months before the screening period, that is, drinking more than 14 units of alcohol per week (1 unit = 285 mL beer or 25 mL 40% alcoholic spirits or 100 mL wine); or during the screening period Alcohol breath test result> 0 mg/100 mL; 17. Those who smoked more than 5 cigarettes per day or habitua
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total radiopharmacokinetic parameters;Cumulative drug excretion rate;Metabolite identification; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, laboratory tests (blood routine, blood biochemistry, coagulation function, thyroid function, urine routine, fecal occult blood), vital signs, 12-lead electrocardiogram, physical examination; | — |
Countries
China
Contacts
Public ContactMiao Liyan
The First Affiliated Hospital of Soochow University
Outcome results
None listed