Healhy subjects and patients with metformin indications
Conditions
Interventions
Case Series:Nil
Sponsors
Department of Clinical Pharmacology, Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects volunteered for the experiment and is willing to test in accordance with the provisions of this test procedure; Sign the informed consent; 2. Volunteers aged 18 - 65 years, including boundary value; 3. Body mass index (BMI) subjects between 18.5 and 35.0 kg/m2; 4. Physical examination without exception discoverer; 5. Vital signs and electrocardiogram examination no obvious abnormalities found; blood pressure in the normal range, sitting systolic blood pressure of 100 - 140mmHg, and sitting diastolic pressure of 60 - 90mmHg; heart rate = 45 times / min and = 100 times / min; 6. The Han nationality in Chinese.
Exclusion criteria
Exclusion criteria: 1. It is known to be allergic or allergic to the test drug and any of its ingredients or related drugs; 2. Such as kidney or liver damage, severe coronary heart disease, congestive heart failure, cerebrovascular disease, hepatitis B or hepatitis C, acquired immunodeficiency syndrome (AIDS), Or cancer or an unstable clinical finding based on the researcher's judgment that may have a negative impact on the study drug treatment or the negative effects of the study drug treatment; 3. Any medications were taken within 2 weeks before screening; 4. participants attended more than 3 clinical trials in the first 1 years of screening, or screened in the first 4 months of the opening of the drug trial, or screened in the first 3 months to participate in the approved drug test; 5. test before 3 months to participate in blood donors; 6. Had a history of alcohol abuse, more than a bottle of beer per day; 7. Smokers (smoking more than 5 cigarettes per day) and 2 weeks before taking the medicine to stop smokers ; 8. Suffering from severe diarrhea in the past 3 months; 9. Suffering from severe chronic constipation in the past 3 months; 10. Antibiotic or probiotic use within 3 months prior to enrollment; 11. The researchers judged that the subjects had poor compliance and could not complete the test as required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary metabolites;Plasma metabolites;Stool metabolites;Gut Microbial DNA; | — |
Countries
China
Contacts
Public ContactZhang Wei
Department of Clinical Pharmacology, Xiangya Hospital, Central South University
Outcome results
None listed