diabetes
Conditions
Interventions
Fasting Group 1:Fasting, Phase 1 for T, Phase 2 for R
Fasting Group 2:Fasting, Phase 1 for R, Phase 2 for T
Fed Group 1:Fed, Phase 1 for T, Phase 2 for R
Fed Group 2:Fed, Phase 1 for R, Phase 2 for T
Sponsors
Beijing Shijitan Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Chinese healthy subjects, gender parity; 2. Aged older than 18 years old; 3. Should be not less than 50 kg weight, body mass index (BMI) 19-28 kg/m2 / BMI = weight/height 2 (including 19 and 28 kg/m2); 4. Health in good condition, not intentional, liver, kidney, gastrointestinal tract, nervous system and history of mental disorder and metabolic abnormalities; 5. Have the ability to communicate with staff normal and in accordance with relevant regulations of the hospital; 6. Test details before the nature, significance, may benefit, inconvenience and potential danger, understand the research program and Voluntarily signed informed consent.
Exclusion criteria
Exclusion criteria: 1. The physical examination, vital signs, abnormal electrocardiogram (ECG) and laboratory examination (to judge by the clinicians have clinical significance); 2. Always have the digestive system disease or a history of digestive surgery (except for appendicitis) affect drug absorption; 3. Have a past history of major disease (spirit of respiratory system, circulatory system and nervous system, etc.), or mental or legal disability; 4. HBsAg test positive or active hepatitis; 5. HIV or TP or hepatitis C antibody test positive; 6. Smoke more than five cigarettes a day, doubt or does history of drug abuse, alcohol intake 3 months more than a day on average two units (1 = 12 ounces or 360 ml beer, 5 ounces, or 150 ml of liquor, 1.5 ounces or 45 ml distilled spirits) or test positive for alcohol; or history of drug or drug abuse; 7. Rounding out the top three months, in another drug test or used the test drug; 8. Test within 30 days before using any drugs inhibit or induce hepatic drug metabolic enzymes; 9. Test used within 2 weeks before any other drugs; 10. Clinically significant history of allergy, especially the history of drug allergy, especially for metformin and allergy to any ingredient in the supplementary material; 11. Three months before the test and offer a blood or blood loss is equal to or more than 500 mL; 12. Pregnant or breastfeeding women, or are pregnant may not acceptable contraceptive methods of women, or pregnancy test positive for and did not take effective contraceptive measures or their spouses program gave birth to six months; 13. Can't tolerate venipuncture blood; 14. Can't guarantee from 48 hours before taking the medicine to the front of the last blood banned smoking and serve grapefruit juice or any food and drinks containing alcohol and xanthine (including chocolate, tea, coffee, coke, etc.); 15. Researcher concludes that the subjects were unable to complete this study, or that the participants involved in this study the other condition that may cause damage.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulse;Respiration;Blood Pressure;ECG;Temperature;Blood Routine Examination;Routine Urine Examination;Blood Biochemical; | — |
Countries
China
Contacts
Public ContactXinghe Wang
Beijing Shijitan Hospital Capital Medical University
Outcome results
None listed