T2DM
Conditions
Interventions
First group:Period 1: Futagliptin Benzoic Acid Tablets (T), period 2: Futagliptin Benzoic Acid capsules (R)
Second group:Period 1: Futagliptin Benzoic Acid capsules (R) , period 2: Futagliptin Benzoic Acid Tablets (T)
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Signed consent inform, acknowledge of content, procedure and potential adverse reactions of study; 2) Followed by study protocol and complete study; 3) Subjects (including their partners) have no pregnancy plan and voluntary to take effective contraceptive measures; 4) Ages 18-65 years old (including 18 and 65 years old), gender including men and women; 5) Body weight: Men >= 50kg, Women >=45kg, BMI=kg/m^2, 18-30 kg/m^2 (including 18-28 kg/m^2); 6) Healthy status: without any history of abnormality of heart, liver, kidney, gastruintestinal tract, nervous, respiratory and metal system, and also metabolic disturbance; 7) Normal or abnormal with no clinical significant physical examination and vital sign.
Exclusion criteria
Exclusion criteria: 1) daily amount of cigarette smoking more than 5 pieces within 3 months prior to study; 2) Allergy to futagliptin or its ingredients or similar drugs, or allergic constitution (multiple drugs and food allergy); 3) History of drugs addicted and/or alcohol abuse (14 units of alcohol per week: 1 unit=285 mL of beer, or 25 mL of liquor, or 100 mL red wine); 4) Blood donation or blood lossing > 450mL prior to administration of drugs; 5) Difficulty in swallowing or history of any GI diseases affecting the absorption of drugs; 6) Any increased risk of hemorrhagic disease, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers; 7) Any drugs that change liver enzyme activity administrated within 14 days prior to screening; 8) Any prescription drugs, OTC, vitamins, healthy care products or herbal medicines within 14 days prior to screening; 9) Combination with inhibitors or inducers of CYP2D6, CYP3A4, P-gp or Bcrp, such as itraconazone, ketoconazone or dronedarone; 10) Special diet (including dragon fruits, mango, pomelo, and/or xanthine-rich food) or strenuous exercise or other factors affecting AMDE of drugs within 2 weeks prior to study; 11) Major changes of a diet or exercise habits within 4 weeks before taking the investigated drugs; 12) Attended the other drugs' clinical trials or taking investigated drugs within 3 months prior to administration of investigated drugs; 13) Clinical abnormality of ECG; 14) Female who has lactation during screening or study or positive serum pregnancy outcomes; 15) Abnormal laboratory test with clinical significances or other clinical significant observations (including but not limit to GI, kidney, liver, nerves, blood, endocrine, tumor, lung, immune, metal or CVD diseases); 16) Positive results of hepatitis B and C, HIV, treponema pallidum antibody; 17) Acute diseases or combination with other drugs from screening to ahead of investigated drugs administration; 18) Patients who consume chocolates or any food or drink containing abundant caffeine or xanthine within 48 hours prior to administration of investigated drugs; 19) Patients who consume alcohol within 24 hours prior to administration of investigated drugs; 20) Positive in test of alcohol or drugs screening or drugs abuse within 5 years or drugs abuse within 3 months prior to study; 21) Others investigators consider that are inadequate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;T1/2z;Laboratory test;AEs;ECG; | — |
Countries
China
Contacts
Public ContactYanhua Ding
The First Hospital of Jilin University
Outcome results
None listed