insomnia
Conditions
Interventions
RTRT group:Qualified participants will be screened and taken on an empty stomach for at least 10 hours overnight on the first day of each dosing cycle. It is expected that the first participant will s
TRTR group:Qualified participants will be selected on the first day of each dosing cycle, after fasting overnight for at least 10 hours. It is expected that the first participant will start taking med
Sponsors
Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The participants fully understood the purpose, nature, methods of the trial, as well as the possible adverse reactions. They voluntarily participated and signed the informed consent form before the trial began. 2. Participants must be healthy adults aged 18 years or above (including 18 years); both men and women are eligible. 3. Body Mass Index (BMI) = weight (kg) / height² (m²), with the BMI ranging from 19.0 to 26.0 kg/m² (including the critical value); male participants should have a weight of no less than 50.0 kg, and female participants should have a weight of no less than 45.0 kg. 4. Participants should be able to communicate well with the researchers, and understand and comply with all the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Those who participated in any drug clinical trials within 3 months before taking the medication or who used the investigational drug; 2. Drug abusers or those who have used soft drugs (such as marijuana) or hard drugs (such as cocaine, phencyclidine, etc.) within one year prior to taking the research drug; 3. There is a history of diseases involving the cardiovascular system, endocrine system, nervous system, blood and lymphatic system, immune system, kidneys, liver, gastrointestinal tract, respiratory system, metabolism (such as hyperkalemia), and bones, and these are judged by the researchers to be abnormal and of clinical significance. 4. Have a history of severe drug allergy, or are of allergic constitution (such as those allergic to two or more drugs, foods or pollen), or are known to be allergic to the components of this medicine or its analogues; 5.Those who cannot tolerate venipuncture or have a history of fainting or experiencing needle shock; 6. Have a history of difficulty in swallowing or any gastrointestinal diseases that affect drug absorption (such as gastrectomy, atrophic gastritis, gastrointestinal bleeding, obstruction, etc.); 7. Those who have undergone surgeries within 6 months before taking the medication, and whose surgeries were judged by the researchers to affect the absorption, distribution, metabolism, and excretion of the drug; or those who plan to undergo surgery during the trial; 8.Those who have a history of spleen removal, liver removal, kidney removal, gallbladder removal or other removal of digestive organs; 9. Those who have donated blood or suffered significant blood loss (= 400 mL) within 3 months before taking the medication, those who have received blood transfusions or used blood products, or those who plan to donate blood or blood components within 3 months during the trial or after the trial; 10.Those who smoked at least 5 cigarettes per day for 3 months before taking the medication, or those who could not stop using any tobacco products during the trial, or those with positive nicotine test results; 11. Those who frequently consumed alcohol within 3 months before taking the medication, that is, those who drank more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine), and who were unwilling to stop drinking alcohol or any alcoholic products during the trial; 12. Those who have used drugs that have drug interactions with melatonin (especially fluvoxamine maleate) or drugs that inhibit/induce the liver's drug metabolism (such as inducers - barbiturates, carbamazepine, etc.; inhibitors - SSRI class antidepressants, cyclosporine, macrolide antibiotics, etc.) within 1 month before taking the medication, caffeine, or CYP1A2 inhibitors (quinolone antibacterial drugs (ciprofloxacin), etc.) are excluded. 13. Those who received vaccinations within one month before taking the medicine, or those who plan to receive vaccinations during the trial; 14. Those who consume excessive amounts of tea, coffee and/or caffeinated beverages every day (more than 8 cups, with 1 cup equaling 250 mL), or those who do not agree to stop drinking tea, coffee and/or caffeinated beverages during the trial; 15. Participants who had a pregnancy plan, sperm donation or egg donation plan within 14 days before taking the medication until 3 months after the end of the trial, or who were unwilling to adopt any non-drug contraceptive measures (such as complete abstinence, co
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters (Cmax, Tmax, AUC0-t, AUC0-8, t1/2); | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory tests (blood routine, blood biochemistry, urine routine); | — |
Countries
China
Contacts
Public ContactGuiling Chen
Shulan (Hangzhou) Hospital
Outcome results
None listed