Insomnia, depression
Conditions
Interventions
Experimental group:On Day 1 and Day 8 of the trial, HS-10506 tablets were orally administered 60 mg (20 mg/tablet/tablet, 3 tablets) on an empty stomach, and on Day 4~Day 8 of the trial, omeprazole ma
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form before the trial, fully understand the content, process and possible adverse reactions of the trial, and self-report to be able to complete the investigator according to the study regulations; 2. Adult males and females (aged 18~45 years, including cut-off values, calculated on the day of signing the informed consent form); 3. Participant's body mass index (BMI) = weight (kg)/height m^2 in the range of 19.0~26.0 kg/m^2 (including critical value); Male participants weighed >=50 kg and female participants weighed >=45 kg; 4. Participants who agree to use highly effective contraception from signing the informed consent form to 3 months after the last dose and have no fertility or sperm/egg donation plans during this period (only non-pharmacological contraception can be used during the trial).
Exclusion criteria
Exclusion criteria: 1. Physically significant abnormalities such as physical examination, vital signs, 12-lead electrocardiogram, clinical laboratory tests, etc., who are judged by the investigator to be unsuitable for enrollment; 2. Hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antibody, and Treponema pallidum antibody during the screening period, any one or more of them are positive; 3. Those who have 12-lead ECG results in the screening period showing QTcF>450 ms for males and QTcF>470 ms for females; 4. Previous diseases of the nervous system, mental system, digestive system, circulatory system, respiratory system (such as abnormal airway anatomy, congenital small tongue, mandibular dysplasia, etc.; chronic obstructive pulmonary disease or sleep apnea syndrome), urinary system and other serious diseases or existing diseases, and are assessed by the investigator to be unsuitable for participating in this investigator; 5. Current or previous psychiatric disorders and brain dysfunction disorders, or participants are at risk of suicide as assessed according to the Columbia Suicide Severity Rating Scale (CSSRS) (Appendix 8), or have self-harming behavior or suicide attempts within one year prior to screening, or are currently at risk of suicide according to the clinical judgment of the researcher; 6. Current or previous history of severe gastrointestinal diseases (such as Crohn's disease, ulcerative colitis, reflux esophagitis, etc.); 7. Those who have a history of surgery within 3 months before screening, or who have expected surgery during the trial, or who have undergone surgery that will affect drug absorption, distribution, metabolism, and excretion, and are judged by the investigator to be unsuitable for enrollment; 8. Those who have participated in any other clinical trials and used any clinical investigational drugs within 3 months before screening, or are within 7 half-lives of other investigational drugs before screening, whichever is longer; 9. Those who are prone to allergic reactions, or allergic constitutions (such as allergies to pollen, two or more drugs/foods), or known allergies to HS-10506 tablets or omeprazole enteric-coated tablets; 10. Those who have a history of drug abuse, drug dependence, or drug use within 5 years before screening, or those who have a positive drug abuse screening result; 11. Regular drinkers (i.e., drinking more than 14 units of alcohol per week, 1 unit = 14 g of alcohol) within 3 months before screening or unable to stop drinking alcoholic products during the trial; 12. Those who have a positive alcohol breath test result; 13. Those who smoke more than 5 cigarettes per day on average within 3 months before screening, or those who cannot stop using any tobacco products during the trial; 14. Excessive intake of tea, coffee, and/or caffeinated beverages in the 3 months prior to screening (average more than 8 cups per day, 1 cup=200 mL); 15. Those who have lost a lot of blood (>=400 mL) or donated blood within 3 months before screening, or donated blood or lost >=200 mL within 1 month, or have blood donation plans during the study period or within 3 months after the end of the study; 16. Those who have used any drugs that can affect CYP3A, CYP2C19 enzymes (see Appendix 4), or alter gastric acid [proton pump inhibitors (PPIs), H2 receptor antagonists, topical antacids, oral alkaline drugs, etc.] within 30 days (or 7 times the corresponding elimination half-life, whichever is longer) b
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Xiangya Third Hospital of Central South University
Outcome results
None listed