None
Conditions
Interventions
Fasting and postprandial group II:Cycle I: Study participants are admitted to a phase I clinical trial research center 1 day before dosing (Day-1) and fasted for at least 10 hours before dosing. On th
Fasting and postprandial group I:Cycle I: Study participants are admitted to the phase I clinical trial research center 1 day before dosing (Day-1) and fasted for at least 10 hours before dosing (excl
Sponsors
The first peoples hospital of loudi
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age>=18 years old, health study participants, male or female; 2. The weight of male study participants >=50.0 kg, the weight of female study participants >=45.0 kg, and the body mass index (BMI) is between 18.5~30.0 kg/m^2 (including boundary values); 3. Study participants voluntarily signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. (Inquiry) Those who have suffered or are currently suffering from any serious clinical 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 the test results (such as: hypotension, hyperkalemia, aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy, renal artery stenosis, primary aldosteronism, liver damage, renal function damage, severe bleeding tendency, etc.); 2. (Inquiry) Lactose intolerance (such as diarrhea after drinking milk); 3. (Inquiry) Those who have the requirement to drive a vehicle and operate a machine during the test; 4. (Inquiry) Those who have a history of allergy to 3 or more substances, or are allergic to any of the ingredients in this product; 5. (Consultation) Those who have undergone surgery within 28 days before taking the study drug for the first time, or plan to undergo surgery during the trial; 6. (Consultation) Those who have used any drugs or health products (including Chinese herbal medicines) within 14 days before taking the study drug for the first time; 7. Those who have used any clinical trial drug or enrolled in any drug/medical device clinical trial within 3 months before taking the study drug for the first time; 8. (Inquiry) Those who donate blood within 3 months before taking the first dose of the study drug, or those who have lost more than 400 mL of blood within 3 months before the first dose of the study drug; 9. (Inquiry) Those who cannot tolerate venipuncture and/or have a history of blood sickness and needle sickness; 10. (Inquiry) Those who have used oral contraceptives within 30 days before taking the study drug for the first time, or those who have used long-acting estrogen or progestogen injections or implants within 6 months before taking the study drug for the first time; 11. (Consultation) Those who have had unprotected sex within 14 days before taking the study drug for the first time (female), or pregnant or lactating female; 12. (Inquiry) Those who cannot take one or more non-drug contraceptive measures during the test, or those who have a birth plan or sperm donation/egg donation plan within 6 months after the end of the test; 13. (Consultation) Those who have special requirements for diet and cannot comply with the uniform diet; 14. (Inquiry) Dysphagia; 15. (Inquiry) Those who drank excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) every day within 3 months before taking the study drug for the first time; 16. (Inquiry) Within 48 hours before taking the study drug for the first time, those who have ingested or plan to ingest any food or beverage containing caffeine (such as coffee, strong tea, chocolate, etc.) or food rich in xanthine (such as sardines, animal liver, etc.) or drink; 17. (Inquiry) Those who have ingested or plan to ingest grapefruit or grapefruit-related citrus fruits (such as lime, grapefruit), star fruit, papaya, pomegranate or above fruit products within 14 days before taking the study drug for the first time; 18. (Inquiry) Smokers or those who smoke more than 5 cigarettes per day within 3 months before taking the study drug for the first time; 19. (Questioning) Alcoholics or regular drinkers within 6 months prior to the first dose of study drug, i.e., drinking more than 14 units of alcohol per week (1 unit ˜ 200 mL of beer with 5% alcoh
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactLiang Haiqiu
The First People's Hospital of Loudi City
Outcome results
None listed