Type 2 Diabetes
Conditions
Interventions
Case Series:Phase I: Metformin Hydrochloride Tablets
Phase II: Metformin Hydrochloride Tablets and Fotagliptin Benzoate Tablets
Phase III: Fotagliptin Benzoate Tablets
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 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) Aged 18 to 45 years old male subjects (including 18 and 45 years old); 5) Body weight: Above 50kg, BMI=kg/m^2, 18-28 kg/m^2 (including 18-28 kg/m^2); 6) Normal hysical examination, vital sign or abnormal but no clinical significance.
Exclusion criteria
Exclusion criteria: 1) Amount of smoking >5 cigarets per day within 3 months prior to study; 2) Allergy to fotagliptin benzoate, metformin hydrochloride and their integridients; 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) High risk in bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic indices; | — |
Countries
China
Contacts
Public ContactYanhua Ding
The First Hospital of Jilin University
Outcome results
None listed