diabetes
Conditions
Interventions
Group D:Fed R-T
Group A:Fasting T-R
Group B:Fasting R-T
Group C:Fed T-R
Sponsors
Beijing Shijitan Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) sign the informed consent voluntarily; (2) healthy volunteers aged 18 years; (3) body mass index was 19.0~28.0kg/m2 (including critical value), male weight 50.0kg, female weight 45.0kg; (4) he/she is in good health and has a medical history of heart, liver, kidney, digestive tract, respiratory system, nervous system and metabolic abnormalities; (5) have the ability to communicate with medical staff, and comply with the relevant hospital management regulations and test requirements.
Exclusion criteria
Exclusion criteria: (1) those who have participated in another drug test or used the drug in this test within three months before being selected; (2) none of the physical examination, vital signs examination, laboratory examination or electrocardiogram examination was done or abnormal (clinically significant after judgment by the clinician); (3) patients with previous digestive diseases or digestive system surgery history (except appendicitis) affecting drug absorption; (4) smoking more than 5 cigarettes a day within 3 months; (5) those with alcohol intake exceeding 14 units per week on average within 3 months (1 unit =10 ml ethanol, that is, 1 unit =200ml beer with 5% alcohol or 25 ml spirit with 40% alcohol or 83 ml wine with 12% alcohol) or positive alcohol test; (6) patients with positive antibody test in virological examination (including hepatitis b, hepatitis c, HIV or TP) (clinically significant upon judgment by clinicians); (7) history of suspected or proven drug abuse; (8) have used any other drugs within two weeks before the start of the trial; (9) any drugs that inhibit or induce hepatic drug metabolic enzymes (e.g., inducers -- barbiturates, carbamazepine, phenytoin, glucocorticoids) were used within 30 days before the test; Inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines, omeprazole); (10) have a significant history of clinical allergy, especially drug allergy, especially to metformin and any ingredients in the adjuvant; (11) have donated or lost blood equal to or more than 400ml within three months before the test, or intend to donate blood or blood components during the test or within three months after the test; (12) women who are pregnant or breast-feeding, or who have the possibility of becoming pregnant but do not use an acceptable method of contraception, or who are positive in pregnancy tests; Men who have not taken effective contraceptive measures or whose spouses plan to give birth within six months; (13) cannot tolerate venipuncture blood collection; (14) it is not guaranteed that smoking and drinking of grapefruit juice or any food or drink containing alcohol or rich in xanthine (including chocolate, tea, coffee, cola, etc.) will be prohibited from 48 hours before taking the medicine until the last blood collection; (15) the researcher considers that the subject should not participate in the test, or the subject cannot participate in the test due to its 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