None listed
Conditions
Interventions
Group 3:In postprandial state, the reference preparation was taken orally in the first cycle, and the test preparation was taken orally in the second cycle, and the cleaning period was 7 days
Group 4:In postprandial state, the test preparation was taken orally in the first cycle, and the reference preparation was taken orally in the second cycle, and the cleaning period was 7 days
Sponsors
Huzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Healthy subjects aged >=18 years, no gender limit; 2. Weight: male weight is not less than 50kg, female weight is not less than 45kg, body mass index [BMI= weight (kg)/height ^2 (m^2)] in the range of 19.0~26.0kg/m^2 (including the boundary value); 3. Female subjects of reproductive age shall take effective and appropriate non-drug contraceptive measures (such as IUD, condom, etc.) from 14 days before the drug administration to 6 months after the study and agree not to donate eggs from 14 days before the drug administration to 6 months after the study; 4. Male subjects must use effective and appropriate non-drug contraception until 6 months after the end of the study and agree not to donate sperm from the start of the drug until 6 months after the end of the study; 5. Subjects must understand the relevant contents and regulations of this study, voluntarily participate in and sign informed consent, and the process of obtaining informed consent shall meet the requirements of GCP; 6. The subjects were able to communicate well with the researchers and complete the study according to the study regulations.
Exclusion criteria
Exclusion criteria: 1. A history of difficulty swallowing or any gastrointestinal disease that affects drug absorption; 2. Patients with serious diseases of the heart, liver, kidney, lung and endocrine system, or with a history of epilepsy, asthma, psychosis and malignant tumors, or with a history of major surgical operations; 3. Patients with a history of hypoglycemia (such as anxiety, dizziness, sweating, tremors, hunger and inattention, etc.); 4. Take any prescription drugs, non-prescription drugs, Chinese patent medicines, Chinese herbs, health care products, etc., within 2 weeks before administration; 5. Those who received the vaccine within 2 weeks before administration; 6. Acute illness occurred within 2 weeks before administration; 7. Patients who donated blood (whole blood or component blood) within 3 months prior to drug administration, or had blood loss greater than 400mL (except for physiological blood loss in women), or planned to donate blood (whole blood or component blood) during the study period or within 3 months after the end of the study; 8. Participated in any other drug clinical trials and took the study drug within 3 months prior to administration; 9. Those who test positive for drug abuse or have a history of drug abuse within the year prior to the test (e.g., morphine, THC, methylamphetamine, dimethylene dioxyamphetamine, ketamine, cocaine, etc.); 10. Patients with abnormalities deemed clinically significant by the investigator based on vital signs, physical examination, electrocardiogram and laboratory tests (blood routine, blood biochemistry, urine routine, pregnancy test, coagulation function, infectious disease screening, and glomerular filtration rate) within 14 days before administration; 11. Allergic to any ingredients in this product and auxiliary materials, or allergic to similar drugs; Or allergic constitution; 12. Patients who drank excessive tea, coffee or caffeinated beverages (more than 8 cups a day, 1 cup =200mL) in the past or could not stop drinking during the study period; 13. Ingestion of any food or drink containing caffeine, alcohol, xanthine and other ingredients (such as coffee, strong tea, chocolate, etc.), grapefruit and any products containing grapefruit within 48 hours before administration; 14. Abnormal alcohol breath detection (>0mg/100mL); Those with a history of alcohol abuse in the year prior to screening and who consumed an average of more than 14 units of alcohol per week in the six months prior to administration (1 unit =360mL beer with 5% alcohol or 45mL spirits with 40% alcohol or 150mL wine with 12% alcohol); 15. Those who smoked more than 5 cigarettes per day on average in the 3 months prior to screening, or who could not accept any tobacco products prohibited during the test period; 16. Those who can't follow the uniform diet or participate in the postprandial group test and are intolerant to high-fat diet; 17. Patients who are dizzy with needle and blood, can not tolerate intravenous indwelling needle blood collection or have difficulty collecting blood; 18. Lactose intolerant (such as diarrhea after drinking milk); 19. Lactating patients; 20. Other situations in which the investigator considered it inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the blood concentration time curve;The peak concentration; | — |
Countries
China
Contacts
Public ContactYang Shuixin
Outcome results
None listed