Diabetes mellitus
Conditions
Interventions
100mg dose group:12 subjects are randomized to receive 3 times oral dose of 100mg yogliptin tablets(n=10) or placebo(n=2)
200mg dose group:12 subjects are randomized to receive 3 times oral dose of 200mg yogliptin tablets(n=10) or placebo(n=2)
400mg dose group:12 subjects are randomized to receive 3 times oral dose of 400mg yogliptin tablets(n=10) or placebo(n=2)
Sponsors
Yunnan Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Age between 18 and 45 (including the boundary value), half males and half females; 2) Female volunteers weighted=48.0 kg, male volunteers weighted=50.0 kg. BMI[weight(kg)/ square of height(m2)] between 19 and 26 kg/?(including the boundary value) 3) Volunteers had no fertility or sperm/egg donation plans and took effective physical contraceptive measures during the study and within 3 months after the end of the study. 4) Before the trial, I understood the nature, significance, possible benefits, possible inconvenience and potential risks and discomfort of the trial in detail, and volunteered to participate in this clinical trial. I can communicate well with the investigator, comply with the requirements of the whole study and have signed a written informed consent form.
Exclusion criteria
Exclusion criteria: 1) Those who are allergic to the study drug (including the study drug excipients) or its analogues and have an allergic constitution (such as those who are allergic to two or more drugs, food and pollen); 2) Patients who have a history of serious clinical diseases and have not been cured, or are suffering from any serious clinical diseases such as cardiovascular, blood system, liver, kidney, digestive tract, nervous system, respiratory system, mental disorders and metabolic disorders, or any other diseases that can interfere with the trail results; 3) Patients who received major surgery within 3 months (90 days) before administration or who received a surgery that may significantly affect the study drugs process in body or its safety evaluation; 4) Those who have used or are using any medicine including vitamins and Chinese herbal medicine within 2 weeks before giving clinical trial drug; 5) Those who have used clinical trial drugs within 3 months before the administration or plan to participate in other clinical trials during the study period; 6) Those who often drink an average of 3 or more times a week and the amount was equal to 200 mL or more 50 degree liquor one time) within 3 months (90 days) or has a test positive for alcohol breath; 7) Those who smoke (more than 10 cigarettes or the same amount of tobacco every day) within 3 months (90 days) before administration or fail to quit during the trial; 8) Blood loss/blood donation exceeded 300 mL (except for female physical blood loss) within 3 months (90 days) before administration, receiving blood transfusion or using blood products, or blood donors are planned during the trial or within 1 month (30 days) after the trial; 9) Those who exceeded consumption of tea, coffee or caffeinated beverage (an average of 8 or more cups per day, 200 mL per cup) within 1 month (30 days) before administration; 10) Those who had a history of drug abuse or positive screening for drug abuse; 11) Results of hepatitis b surface antigen, hepatitis c virus antibody, treponema pallidum antibody or human immunodeficiency virus antibody were positive in the screening period; 12) Physical examination, vital signs, laboratory examination ( blood routine, urine routine, stool routine, blood biochemistry, liver function, renal function, electrolyte, amylase, lipase, blood lipid, fasting blood sugar), blood coagulation function, B ultrasonic of upper abdomen, chest orthotopic examination or 12-lead electrocardiogram results have clinical significance by clinical physicians during screening period. 13) women who are pregnant, possible to be pregnant, lactating or have positive pregnancy test during the trial period; 14) Those who a history of needle sickness, blood sickness or inability to tolerate venipuncture; 15) Those who have special dietary requirements or cannot comply with the uniform diet; 16) Volunteers who may be unable to complete the study for other reasons or may not be considered by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety (monitoring of adverse events (AEs), physical examination, vital signs, clinical laboratory tests and 12-lead electrocardiograms (ECGs), chest X-ray, etc);pharmacokinetic parameters (Tmax, Cmax, AUC, t1/2, Vz, CLz, etc.);phamacodynamics (percent inhibition of plasma DPP-4 activity); | — |
Countries
China
Contacts
Public ContactJianchang He
Yunnan Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed