Type 2 diabetes mellitus
Conditions
Interventions
first-period experimental group:Subjects will be given Glucophage or domestic metformin tablets by 0.5g
second-period experimental group:Subjects will be given domestic metformin tablets or Glucophage by 0.5g (crossover)
Sponsors
Shandong Provincial Qianfoshan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Age:18~40 years old; 2. Weight:>=50Kg; BMI: male 20~25kg/m2, female19~24kg/m2; 3. Subjects must be healthy,without cardiovascular, liver, kidney, gastrointestinal tract, nervous system, mental or metabolic disorders and other medical history; 4. HbA1c<6.5%, FPG3.89-6.1mmol/L with PPG 6.7-9.4mmol/L; 5. Patients volunteered to participate in this study, and signed informed consent file.
Exclusion criteria
Exclusion criteria: 1. subjects in Pregnancy or lactation period; 2. subjects have taken hypoglycemic drugs in 2 months; 3. subjects have accepted induct or inhibit cytochrome P450 3A4 treatment, systemic corticosteroid therapy,antiviral therapy of immunodeficiency disease; 4. subjects have accepted gastrointestinal operation that affect the absorption of drugs; 5. subjects with hemoglobin or acute progressive renal disease or autoimmune skin disease history; 6. subjects with the behavious: drug abuse and alcoholism in a year; 7. subjects with treatment contraindications mentioned in drug specifications; 8. subejects with a history of acute or chronic pancreatitis, or acute or chronic pancreatitis; 9. subjects with New York Heart Association (NYHA) grade III or IV congestive heart failure and / or left ventricular ejection fraction of 40% or less, or with a history of cardiovascular disease significant over the past six months: myocardial infarction, coronary angioplasty or bypass operation, valvular disease or repair, unstable angina, transient ischemic attack or brain internal vascular accident; 10. subjects with obviously abnormal onLiver function,defined as AST>2*ULN and/or ALT2*ULN and/or total bilirubin >34umol/L or with positive serology of infectious hepatitis; 11. subjects with obvious clinical signs or symptoms of liver disease, acute active hepatitis or chronic active hepatitis; 12. subjects with clinically abnormalities that affect healthy or affect to participate study according to the judgment in laboratory examination and physical examination or ECG; 13. CrCl<=90ml/min.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| bioequivalence;plasma drug concentration; | — |
Countries
China
Contacts
Public ContactLi Yan
Outcome results
None listed