diabetes
Conditions
Interventions
Fasting T-R group:Subjects took the test preparation in the first cycle, and took the reference preparation in the second cycles
Fasting R-T group:Subjects took the reference preparation in the first cycle, and took the test preparation in the second cycles
Postprandial T-R group:In the postprandial state, subjects took the test preparation in the first cycle, and took the reference preparation in the second cycles
Postprandial R-T group:In the postprandial state, subjects took the reference preparation in the first cycle, and took the test preparation in the second cycles
Sponsors
Huzhou Central Hospital, Zhejiang Province
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The subject fully understands the purpose, nature, method, and potential adverse reactions of the experiment, voluntarily serves as the subject, and signs an informed consent form before any research procedure begins, and guarantees that any procedure will involve the subject's participation in the study; 2. For male and female subjects aged = 18 years, the sex ratio is appropriate; 3. Male weight = 50.0kg, female weight = 45.0kg; Body mass index (BMI) within the range of 19.0-26.0kg/m2 (including critical values); 4. Vital sign examination, physical examination, clinical laboratory examination (blood routine examination, urine routine examination, blood biochemistry, blood transfusion, blood coagulation function, pregnancy examination (women only), etc.), 12 lead ECG, and the results show that there is no abnormality or abnormality has no clinical significance; 5. The subjects are able to communicate well with the researchers and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Individuals with a history of allergies to cetagliptin phosphate or any drug component, as well as a history of food or other drug allergies; 2. Individuals with a history of hypersensitivity reactions (such as allergic reactions, vascular edema, exfoliative skin damage, etc.); 3. Individuals with a history of orthostatic hypotension; 4. Individuals with a history of bullous pemphigoid; 5. People with dysphagia or any history of gastrointestinal diseases affecting absorption; 6. Those who have undergone surgery within 3 months before screening, or who plan to undergo surgery during the study period, and those who have undergone surgery that will affect absorption, distribution, metabolism, and excretion; 7. Diseases with abnormal clinical manifestations that need to be excluded, including but not limited to neurological, cardiovascular, blood and lymphatic systems, immune systems, kidneys, liver, gastrointestinal, respiratory, metabolic, and skeletal system diseases; 8. There are conditions that may significantly affect the absorption, distribution, metabolism and excretion of absorption, medical history related to the effect of the test drug and any other conditions; 9. Those who cannot tolerate venous puncture or have had difficulty collecting blood in the past; 10. Screening for individuals with a history of drug abuse within the first 6 months; 11. Screening for individuals who have used drugs within the first three months; 12. Those who have participated in other drug clinical trials within the first three months of screening and have taken investigational drugs or have not participated in clinical trials in person; 13. Those who donate blood within the first 3 months of screening, including blood components or have lost a large amount of blood (= 200mL), receive blood transfusions or use blood products; 14. The subject (female) is in the lactation period; Unprotected sexual activity (female) occurred two weeks before screening; 15. Subjects (females) who have positive pregnancy test results during the screening period or the trial process; 16. During the experimental period until 6 months after the last administration of the study drug, there is a fertility plan, and there are individuals who are unwilling to take appropriate contraceptive measures or have plans to donate sperm or eggs; 17. Those who have used any medication that interacts with silagliptin (such as P-glycoprotein inhibitors ketoconazole, cyclosporine A, etc.) within 28 days prior to taking the study drug; 18. Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, and vitamins within 2 weeks before administration; 19. Those who have received vaccination within 4 weeks before screening; 20. Those who smoke more than 5 cigarettes per day within the first 3 months of screening, or who cannot stop using any tobacco products during the trial period; 21. Those who consume more than 14 units of alcohol per week (1 unit of alcohol ˜ 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) within the first 3 months of screening, or who cannot abstain from alcohol during the trial period; 22. Individuals who consume excessive amounts of tea, coffee, and/or caffeinated beverages (8 or more cups, 1 cup=250 mL) every day within the first 3 months of screening; 23. Those who have consumed dragon fruit, mango, grapefruit, lime, carambola, or food or beverages prepared from them within 7 days before administration; 24. Those who have spec
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| ?z;t1/2;AUC_%Extrap; | — |
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration;Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactYang Shuixin
Huzhou Central Hospital, Zhejiang Province
Outcome results
None listed