diabetes
Conditions
Interventions
Fast Group 1:T-R
Fast Group 2:R-T
Sponsors
Beijing Shijitan Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
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.;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.;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.;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.;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. No abnormal results or abnormal results of physical examination, vital signs, laboratory tests, electrocardiogram, as judged by the Investigator; 2. Historyof diseases (except for appendicitis)or surgeryon digestive system which can affect drug absorbing; 3. A positive result of testfor hepatitis B surface antigen (HBsAg) or a hepatitis Bcarrier; 4. A positive result of testfor hepatitis C antibody, HIV antibody or syphilis; 5. More than 5 cigarettes per day on average or average alcohol intake was over 2 units per daywithin 3 months(at least 14 units of alcohol per week: 1 units = 285 mL beer, 25 mL spirit or 100 mL wines), orpeople with a positiveresult ofbreath alcohol test; 6. Doubtfully or indeed having a history of drug abuse; 7. Have participated in other drug clinical study within 3 months prior to receiving study medication; 8. Have taken any drugs that inhibit or induce the activity of liver drug-metabolism enzyme (such as: inducer - barbiturates, carbamazepine, phenytoin, glucocorticoid;Inhibitors-SSRI cimetidine, diltiazole, nitromidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines, omeprazole); 9. Use of any other drugs within 2 weeks prior to receiving this study; 10. Clinically significant history of allergy, in particular, a history of drug allergy, especially for metformin and any of the constituents of the excipients; 11. Donation or loss of a significant volume of blood (400 mL) within 3 months prior to receiving study medication, or intend to donate blood or blood components within three months of the study or after the study; 12. Female subject have pregnancy or is lactating, having possibility of pregnancy and may not adopt acceptable contraceptive methods, or a pregnancy test positive and did not take effective contraceptive measures or their spouses plan pregnancy within six months; 13. Cannot tolerate venipuncture blood; 14. Can't guarantee to quit smoking and to not take grapefruit juice or any food and drinks containing alcohol orrichcontaining xanthine (including chocolate, tea, coffee, coke, etc.) from 48 hours before taking the medicine to the completion of the last blood sampling; 15. Investigatorjudges subjects are unable to complete this study, or that the subjects will be harmed or having other conditions.;Exclusion criteria: 1. No abnormal results or abnormal results of physical examination, vital signs, laboratory tests, electrocardiogram, as judged by the Investigator; 2. Historyof diseases (except for appendicitis)or surgeryon digestive system which can affect drug absorbing; 3. A positive result of testfor hepatitis B surface antigen (HBsAg) or a hepatitis Bcarrier; 4. A positive result of testfor hepatitis C antibody, HIV antibody or syphilis; 5. More than 5 cigarettes per day on average or average alcohol intake was over 2 units per daywithin 3 months(at least 14 units of alcohol per week: 1 units = 285 mL beer, 25 mL spirit or 100 mL wines), orpeople with a positiveresult ofbreath alcohol test; 6. Doubtfully or indeed having a history of drug abuse; 7. Have participated in other drug clinical study within 3 months prior to receiving study medication; 8. Have taken any drugs that inhibit or induce the activity of liver drug-metabolism enzyme (such as: inducer - barbiturates, carbamazepine, phenytoin, glucocorticoid;Inhibitors-SSRI cimetidine, diltiazole, nitromidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines, omeprazole); 9. Use of any other drugs within 2 weeks prior to receiving this study; 10. Clinically significant history of allergy, in particular, a history of drug allergy, especially for metformin and any of the constituents of the excipients; 11. Donation or loss of a significant volume of blood (400 mL) within 3 months prior to receiving study medication, or intend to donate blood or blood components within three months of the study or after the study; 12. Female subject have pregnancy or is lactating, having possibility of pregnancy and may not adopt acceptable contraceptive methods, or a pregnancy test positive and did not take effective contraceptive measures or their spouses plan pregnancy within six months; 13. Cannot tolerate venipuncture blood; 14. Can't guarantee to quit smoking and to not take grapefruit juice or any food and drinks containing alcohol orrichcontaining xanthine (including chocolate, tea, coffee, coke, etc.) from 48 hours before taking the medicine to the completion of the last blood sampling; 15. Investigatorjudges subjects are unable to complete this study, or that the subjects will be harmed or having other conditions.;Exclusion criteria: 1. No abnormal results or abnormal results of physical examination, vital signs, laboratory tests, electrocardiogram, as judged by the Investigator; 2. Historyof diseases (except for appendicitis)or surgeryon digestive system which can affect drug absorbing; 3. A positive result of testfor hepatitis B surface antigen (HBsAg) or a hepatitis Bcarrier; 4. A positive result of testfor hepatitis C antibody, HIV antibody or syphilis; 5. More than 5 cigarettes per day on average or average alcohol intake was over 2 units per daywithin 3 months(at least 14 units of alcohol per week: 1 units = 285 mL beer, 25 mL spirit or 100 mL wines), orpeople with a positiveresult ofbreath alcohol test; 6. Doubtfully or indeed having a history of drug abuse; 7. Have participated in other drug clinical study within 3 months prior to receiving study medication; 8. Have taken any drugs that inhibit or induce the activity of liver drug-metabolism enzyme (such as: inducer - barbiturates, carbamazepine, phenytoin, glucocorticoid;Inhibitors-SSRI cimetidine, diltiazole, nitromidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines, omeprazole); 9. Use of any other drugs within 2 weeks prior to receiving this study; 10. Clinically significant history of allergy, in particular, a history of drug allergy, especially for metformin and any of the constituents of the excipients; 11. Donation or loss of a significant volume of blood (400 mL) within 3 months prior to receiving study medication, or intend to donate blood or blood components within three months of the study or after the study; 12. Female subject have pregnancy or is lactating, having possibility of pregnancy and may not adopt acceptable contraceptive methods, or a pregnancy test positive and did not take effective contraceptive measures or their spouses plan pregnancy within six months; 13. Cannot tolerate venipuncture blood; 14. Can't guarantee to quit smoking and to not take grapefruit juice or any food and drinks containing alcohol orrichcontaining xanthine (including chocolate, tea, coffee, coke, etc.) from 48 hours before taking the medicine to the completion of the last blood sampling; 15. Investigatorjudges subjects are unable to complete this study, or that the subjects will be harmed or having other conditions.;Exclusion criteria: 1. No abnormal results or abnormal results of physical examination, vital signs, laboratory tests, electrocardiogram, as judged by the Investigator; 2. Historyof diseases (except for appendicitis)or surgeryon digestive system which can affect drug absorbing; 3. A positive result of testfor hepatitis B surface antigen (HBsAg) or a hepatitis Bcarrier; 4. A positive result of testfor hepatitis C antibody, HIV antibody or syphilis; 5. More than 5 cigarettes per day on average or average alcohol intake was over 2 units per daywithin 3 months(at least 14 units of alcohol per week: 1 units = 285 mL beer, 25 mL spirit or 100 mL wines), orpeople with a positiveresult ofbreath alcohol test; 6. Doubtfully or indeed having a history of drug abuse; 7. Have participated in other drug clinical study within 3 months prior to receiving study medication; 8. Have taken any drugs that inhibit or induce the activity of liver drug-metabolism enzyme (such as: inducer - barbiturates, carbamazepine, phenytoin, glucocorticoid;Inhibitors-SSRI cimetidine, diltiazole, nitromidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines, omeprazole); 9. Use of any other drugs within 2 weeks prior to receiving this study; 10. Clinically significant history of allergy, in particular, a history of drug allergy, especially for metformin and any of the constituents of the excipients; 11. Donation or loss of a significant volume of blood (400 mL) within 3 months prior to receiving study medication, or intend to donate blood or blood components within three months of the study or after the study; 12. Female subject have pregnancy or is lactating, having possibility of pregnancy and may not adopt acceptable contraceptive methods, or a pregnancy test positive and did not take effective contraceptive measures or their spouses plan pregnancy within six months; 13. Cannot tolerate venipuncture blood; 14. Can't guarantee to quit smoking and to not take grapefruit juice or any food and drinks containing alcohol orrichcontaining xanthine (including chocolate, tea, coffee, coke, etc.) from 48 hours before taking the medicine to the completion of the last blood sampling; 15. Investigatorjudges subjects are unable to complete this study, or that the subjects will be harmed or having other conditions.;Exclusion criteria: 1. No abnormal results or abnormal results of physical examination, vital signs, laboratory tests, electrocardiogram, as judged by the Investigator; 2. Historyof diseases (except for appendicitis)or surgeryon digestive system which can affect drug absorbing; 3. A positive result of testfor hepatitis B surface antigen (HBsAg) or a hepatitis Bcarrier; 4. A positive result of testfor hepatitis C antibody, HIV antibody or syphilis; 5. More than 5 cigarettes per day on average or average alcohol intake was over 2 units per daywithin 3 months(at least 14 units of alcohol per week: 1 units = 285 mL beer, 25 mL spirit or 100 mL wines), orpeople with a positiveresult ofbreath alcohol test; 6. Doubtfully or indeed having a history of drug abuse; 7. Have participated in other drug clinical study within 3 months prior to receiving study medication; 8. Have taken any drugs that inhibit or induce the activity of liver drug-metabolism enzyme (such as: inducer - barbiturates, carbamazepine, phenytoin, glucocorticoid;Inhibitors-SSRI cimetidine, diltiazole, nitromidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines, omeprazole); 9. Use of any other drugs within 2 weeks prior to receiving this study; 10. Clinically significant history of allergy, in particular, a history of drug allergy, especially for metformin and any of the constituents of the excipients; 11. Donation or loss of a significant volume of blood (400 mL) within 3 months prior to receiving study medication, or intend to donate blood or blood components within three months of the study or after the study; 12. Female subject have pregnancy or is lactating, having possibility of pregnancy and may not adopt acceptable contraceptive methods, or a pregnancy test positive and did not take effective contraceptive measures or their spouses plan pregnancy within six months; 13. Cannot tolerate venipuncture blood; 14. Can't guarantee to quit smoking and to not take grapefruit juice or any food and drinks containing alcohol orrichcontaining xanthine (including chocolate, tea, coffee, coke, etc.) from 48 hours before taking the medicine to the completion of the last blood sampling; 15. Investigatorjudges subjects are unable to complete this study, or that the subjects will be harmed or having other conditions.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Blood Pressure;Pulse;Temperature;ECG;Blood Routine Examination;Routine Urine Examination;Blood Biochemical;breathing; | — |
Countries
China
Contacts
Public ContactXinghe Wang;Xinghe Wang;Xinghe Wang;Xinghe Wang;Xinghe Wang ;;;;
Beijing Shijitan Hospital Capital Medical University;Beijing Shijitan Hospital Capital Medical University;Beijing Shijitan Hospital Capital Medical University;Beijing Shijitan Hospital Capital Medical University;Beijing Shijitan Hospital Capital Medical University
Outcome results
None listed