None listed
Conditions
Interventions
Group 3:In the postprandial state, the reference preparation was taken orally in the first cycle, and the test preparation was taken orally in the second cycle. The cleaning period was 7 days
Group 4:In the 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 over 18 years (including 18 years old), 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)] within the range of 19.0~26.0kg/m^2 (including boundary values); 3. Female subjects of reproductive age shall take effective and appropriate non-drug contraceptives (such as intrauterine devices, condoms, etc.) from 14 days before medication to 6 months after study completion, and agree not to donate eggs from 14 days before medication to 6 months after study completion; 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. Subjects are able to communicate well with researchers and complete the study according to 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, mental illness and malignant tumours, 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, over-the-counter drugs, Chinese patent medicines, Chinese herbs, health 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. Blood donation (whole blood or component blood) within 3 months prior to administration, blood loss greater than 400mL (except physiological blood loss in women), or blood donation (whole blood or component blood) planned 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, tetrahydrocannabinol, methylamphetamine, dimethylene dioxyamphetamine, ketamine, cocaine, etc.); 10. Patients with abnormalities deemed clinically significant by the investigator within 14 days prior to administration 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); 11. Allergic to any ingredient in this product and auxiliary materials, or allergic to similar drugs; Or allergic constitution; 12. Patients who drink excessive tea, coffee or caffeinated beverages in the past (more than 8 cups a day, 1 cup =200mL) or cannot 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 breath detection of alcohol (>0mg/100mL); A history of alcohol abuse in the year prior to screening and an average weekly consumption of more than 14 units of alcohol in the six months prior to administration (1 unit =360mL 5% alcohol beer or 45mL 40% alcohol spirits or 150mL 12% wine); 15. Those who smoked more than 5 cigarettes per day on average in the 3 months prior to screening, or who could not accept the prohibition of any tobacco products during the test; 16. Those who cannot follow a uniform diet or participate in the postprandial group test and are intolerant to high-fat diet; 17. Patients with needle fainting and blood fainting, patients who cannot tolerate venous indwelling needle blood collection or patients with difficulty in blood collection; 18. Lactose intolerant patients (such as diarrhea after drinking milk); 19. Lactating female patients; 20. Other situations in which the researchers did not consider participation in the study appropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the blood concentration curve;Blood concentration; | — |
Countries
China
Contacts
Public ContactYang Shuixin
Outcome results
None listed