Diabetes mellitus
Conditions
Interventions
2.5mg dose group:12 subjects are randomized to receive single oral dose of 2.5mg yogliptin tablets(n=10 ) or placebo(n=2)
5mg dose group:12 subjects are randomized to receive single oral dose of 5mg yogliptin tablets(n=10 ) or placebo(n=2)
10mg dose group:12 subjects are randomized to receive single oral dose of 10mg yogliptin tablets(n=10 ) or placebo(n=2)
25mg dose group:12 subjects are randomized to receive single oral dose of 25mg yogliptin tablets(n=10 ) or placebo(n=2)
50mg dose group:12 subjects are randomized to receive single oral dose of 50mg yogliptin tablets(n=10 ) or placebo(n=2)
100mg dose group:12 subjects are randomized to receive single oral dose of 100mg yogliptin tablets(n=10 ) or placebo(n=2)
200mg dose group:12 subjects are randomized to receive single oral dose of 200mg yogliptin tablets(n=10 ) or placebo(n=2)
400mg dose group:12 subjects are randomized to receive single oral dose of 400mg yogliptin tablets(n=10 ) or placebo(n=2)
600mg dose group:8 subjects are randomized to receive single oral dose of 600mg yogliptin tablets(n=6) or placebo(n=2)
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Healthy subjects, aged from 18 to 45 years old, male or female, and with a body mass index of 19-28kg/m2, are included in the trial. All subjects are in good health condition examined by medical history, complete physical examination, 12-lead electrocardiograms (ECGs), Doppler ultrasound of upper abdomen, chest X-ray and clinical laboratory tests, including standard hematology (red blood cells, leukocytes total and differential, platelets, hemoglobin, and hematocrit, etc.), blood chemistry (creatinine, urea nitrogen, alanine aminotransferase, aspartate aminotransferase, total protein, albumin, total bilirubin, conjugated bilirubin, unconjugated bilirubin, glucose, lipid profiles, electrolytes, lipase, amylase, etc.), cogulation function, urine analysis, stool rountine test. For female subjects of childbearing potential, no birth plan within previous 1 month and throughout the study period, serum pregnancy test must be negative and agree to use effective methods of contraception during the study and for 3 months after administration of the study drug. Subjects will be capable of giving written informed consents voluntarily, and agree to comply with the requirements of clinical protocols.
Exclusion criteria
Exclusion criteria: Subjects will be excluded if they have any clinically significant abnormalities at physical examination; any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, hematologic, endocrine and metabolic, immunologic, Familial hereditary diseases, neurologic, psychiatric, or infectious disease; positive serologic findings for HIV antibodies, hepatitis B surface antigen (HBsAg), and HCV(hepatitis C virus) antibody. In addition, any alcohol or drug abuse; allergy or hypersensitivity to the study drug; females with pregnancy and lactation; blood donation within the previous 3 months; participation in another investigational drug study within the previous 3 months; used any drugs (including herbal supplements )within 2 weeks before the study; any other ineligible conditions for inclusion into the study according to the investigators judgement are excluded from participation.
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.); | — |
Secondary
| Measure | Time frame |
|---|---|
| phamacodynamics (percent inhibition of plasma DPP-4 activity); | — |
Countries
China
Contacts
Public ContactZhongping Gou
Institue of National Drug Clinical Trail/GCP center, West China Hospital, Sichuan University
Outcome results
None listed