Healthy people
Conditions
Interventions
Group ?:T(test)-R(control)-T(test)-R(control)
Group ?:R(control)-T(test)-R(control)-T(test)
Sponsors
Yue Bei People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1)Healthy male or female Chinese adults, aged 18 or older (2)Body mass indexes (BMIs) ranging from 19 to 26 kg/m2, and weights higher than 50kg,weights higher than 45kg; (3)Willing to participate the trial and signed informed consent forms
Exclusion criteria
Exclusion criteria: 1) Individuals who have previously or currently suffered from any clinically severe diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, or any other diseases that can interfere with test results (such as known biliary cirrhosis, cholestasis, etc.); 2) Individuals who have a history of allergies to drugs, food, or other substances, or are allergic to any ingredients in this product; 3) Those who have undergone surgery within 28 days before the trial, or plan to undergo surgery during the trial period; 4) Those who have used any medication or health products (including Chinese herbal medicine) within 14 days before the experiment; 5) Those who have used any drugs that inhibit or induce liver metabolism of drugs within 30 days before the experiment (such as inducers - barbiturates, carbamazepine, phenytoin sodium, rifampicin; inhibitors - SSRI antidepressants, cimetidine, cyclosporine, macrolides, verapamil, quinolones, pyrrole antifungal drugs, HIV protease inhibitors, etc.); 6) Those who have used any clinical trial drug or enrolled in any drug clinical trial within 3 months prior to the trial; 7) Blood donors within 3 months prior to the experiment, or those who have lost more than 400 mL of blood within 3 months prior to the experiment; 8) Those who cannot tolerate venous puncture and/or have a history of blood or needle sickness; 9) Those who have used oral contraceptives within 30 days before the experiment, or those who have used long-acting estrogen or progesterone injections or implants within 6 months before the experiment; 10) Have had unprotected sexual activity (female) within 14 days before the experiment, or have been pregnant or lactating; 11) Those who are unable to take one or more non pharmacological contraceptive measures during the trial period; 12) Those who have special dietary requirements and cannot follow a unified diet or have difficulty swallowing; 13) Those who consume excessive amounts of tea, coffee, or caffeinated beverages (8 or more cups, 1 cup=250 mL) every day within 3 months prior to the experiment; 14) Those who have taken or plan to take any food or drink containing caffeine (such as coffee, strong tea, chocolate, etc.) or food rich in xanthine (such as sardine, animal liver, etc.) or drink within 48 hours before taking the study drug for the first time; 15) Those who have consumed or plan to consume grapefruit or grapefruit related citrus fruits (such as lime, grapefruit), carambola, papaya, pomegranate, or other fruit products within 14 days prior to the first administration of the study drug; 16) Alcoholics or those who frequently drink alcohol within the 6 months prior to the experiment, i.e. drink more than 14 units of alcohol per week (1 unit ˜ 200? ML of beer with 5% alcohol content, 25? ML of spirits with 40% alcohol content, or 85? ML of wine with 12% alcohol content); 18) Drug abusers or those who have used soft drugs (such as marijuana) within 3 months prior to the trial, or those who have used hard drugs (such as cocaine, phencyclidine, etc.) within 1 year prior to the trial; 19) Irregular bowel movements within 7 days prior to the experiment; 20) Individuals with clinically significant abnormal vital signs [reference value range: 90 mmHg = systolic blood pressure<140 mmHg, 60 mmHg = diastolic blood pressure<90 mmHg, 60 beats/min = pulse (resting) = 100 beats/min; Based
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-8;AUC0-t; | — |
Countries
China
Contacts
Public ContactWenmao Fan
Yue Bei People's Hospital
Outcome results
None listed