None (healthy people)
Conditions
Interventions
Group ?:T(test drug)-R(control drug)-T(test drug)-R(control drug)
Group ?:R(control drug)-T(test drug)-R(control drug)-T(test drug)
Sponsors
Yue Bei People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: (1)Healthy male or female Chinese adults, aged 18 or older (2)The weight of male subjects is = 50.0 kg, the weight of female subjects is = 45.0 kg, and the body mass index (BMI) is between 19-26 kg/m2 (including boundary values); (3)Willing to participate the trial and signed informed consent forms
Exclusion criteria
Exclusion criteria: 1) (Consultation) Any clinical serious illness or any other disease that can interfere with test results, such as digestive ulcers, gastrointestinal bleeding, thrombocytopenia, hemorrhagic constitution, coagulation dysfunction, liver or kidney failure, that has been or is currently suffering from circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities History of asthma caused by salicylates or substances containing salicylates or nonsteroidal anti-inflammatory drugs, as well as glucose-6-phosphate dehydrogenase (G6PD) deficiency, etc; 2) (Consultation) Individuals with a history of allergies to drugs, food, or other substances, or allergies to any ingredients in this product; 3) (Consultation) Those who have undergone surgery within 28 days before the first administration of the investigational drug or plan to undergo surgery during the trial period; 4) (Consultation) Those who have used any medication or health supplements (including Chinese herbal medicine) within 14 days before the first administration of the study drug; 5) (Consultation) Those who have used any drugs that inhibit or induce liver metabolism of drugs (such as inducers - barbiturates, carbamazepine, phenytoin sodium, rifampicin; inhibitors - SSRI antidepressants, cimetidine, cyclosporine, macrolides, verapamil, quinolones, pyrrole antifungal drugs, HIV protease inhibitors, etc.) within 30 days before the first administration of the study drug; 6) (Consultation) Individuals who have used any clinical trial drug or enrolled in any drug/medical device clinical trial within the first 3 months prior to taking the study drug; 7) (Consultation) Blood donors within 3 months prior to the first administration of the study drug, or those who have lost more than 400 mL of blood within 3 months prior to the first administration of the study drug; 8) (Consultation) Those who cannot tolerate venous puncture and/or have a history of dizziness or needle fainting; 9) (Consultation) Those who have used oral contraceptives within 30 days before the first use of the study drug, or those who have used long-acting estrogen or progesterone injections or implants within 6 months before the first use of the study drug; 10) (Consultation) Have had unprotected sexual activity (female) within the first 14 days prior to taking the investigational medication, or have been pregnant or breastfeeding women; 11) (Consultation) Those who are unable to use one or more non pharmacological contraceptive measures during the trial period; 12) (Consultation) Those who have special dietary requirements and cannot follow a unified diet or have difficulty swallowing; 13) (Consultation) Individuals who consume excessive amounts of tea, coffee, or caffeinated beverages (8 or more cups, 1 cup=250 mL) daily within the first 3 months prior to taking the investigational medication; 14) (Interview) 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) (Consultation) Those who have consumed or plan to consume grapefruit or grapefruit related citrus fruits (such as lime, grapefruit), carambola, papaya, pomegranate or above fruit products within 14 days before the first administration of the study drug; 16
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