diabetes
Conditions
Interventions
Group A:Fasting T-R (850mg)
Group B:Fasting R-T (850mg)
Group C:Fed T-R (850mg)
Group D:Fed R-T (850mg)
Sponsors
Beijing Shijitan Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Chinese healthy subjects older than 18 years of age; 2. At least 50 kg for male subjects, 45 kg for female subjects, with a Body Mass Index (BMI= Weight/Height2 kg/m2) between 19.0-28.0, inclusive; 3. Health conditions: no history of diseases in heart, liver, kidney, digestive tract and nervous system, no history of mental abnormality and metabolic abnormality diseases; 4. Ableto communicate with medical staff and comply with the relevant regulationsofthe hospital; 5. Able to communicate well with researchers, understand and comply with research requirements; 6. Consent to sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Clinically, there is a remarkable history of allergic reactions, especially in the history of drug allergy, especially in metformin and any ingredients in the adjuvant; 2. Any disease that may affect the absorption of the drug, such as dysphagia or digestive diseases; 3. Patients with venous blood collection, or a history of motion sickness and blood loss; 4. Have any clinical history of serious disease or cardiovascular system, endocrine system disease or lung, hematology, immunology and metabolic abnormalities; 5. Physical examination, inspection and vital signs and laboratory tests (blood routine, routine urine and blood biochemical), abnormal results of 12 - lead electrocardiogram examination and clinical significance of this test evaluation and influential; 6. Hepatitis b virus surface antigen, hepatitis c virus antibody, treponema pallidum antibody or human immunodeficiency virus antibody test results are positive; 7. Any drug that inhibits or induces hepatic drug metabolism enzymes in the first 30 days of the trial (e.g., inducer - barbiturates, carbazepine, phenytoin sodium, glucocorticoid; Inhibitors - SSRI antidepressants, cimetidine, diltiazem, large ring lactone class, nitro imidazoles, sedative hypnotics, verapamil, fluoroquinolone, antihistamines, omeprazole); 8. Any other drugs were used within the first two weeks of the trial; 9. Smoking is more than five cigarettes a day, doubt or does history of drug abuse, alcohol intake every day an average of more than 3 months 2 unit (= 1 unit 10 mL of ethanol, which is 1 unit = 200 mL of alcohol content of 5% beer or 25 mL of 40% alcohol liquor or 83 mL wine alcohol content of 12%) or test positive for alcohol; 10. Participated in any drug clinical trial within 3 months prior to the trial; 11. Blood donation or blood loss was greater than 400 mL within 3 months before the test. 12. Failure to comply with the central standard diet; 13. It is not guaranteed to ban the smoking of grapefruit juice or any foods and beverages containing alcohol and xanine (including chocolate, tea, coffee, cola, etc.) from the first 48 hours to the last blood collection. 14. Women who are pregnant during pregnancy, lactation or plan to be pregnant during the trial period, as well as men or women who are not willing to use barrier contraceptives during the entire trial period to 6 months after the end of the trial; 15. The study participants were not allowed to participate in the experiment, or the subjects could not participate in the experiment for their own reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Pressure;Pulse;Temperature;ECG;Blood Routine Examination;Routine Urine Examination;Blood Biochemical; | — |
Countries
China
Contacts
Public ContactXinghe Wang
Beijing Shijitan Hospital Capital Medical University
Outcome results
None listed