T2DM
Conditions
Interventions
Self control:diet, treatment
Sponsors
First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Male or female aged 18 and 65 years old; 2) Body weight >=50kg, BMI 19 to 28kg/m2; 3) have no medical history and have clinical laboratoryvital sighEGG and other relative tests results within the normal range for the population or investigator site, or with abnormalities deemed clinically insignificant by the investigator; 4) No smoking, drinking and other bad habits; no drug abuse history; 5) No known history of allergy to drugs and biologics. 6) non-childbearing potential female, pregnancy test was negative; 7) are willing to make themselves available for the duration of the study, have given written informed consent approved by Yabao and the ethical review board governing the site.
Exclusion criteria
Exclusion criteria: 1) Have clinical laboratoryvital sighEGGchest radiograph and other relative tests results out of the normal range for the population or investigator site, or with abnormalities deemed clinically significant by the investigator; 2) Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (especially the history of pancreatitis), endocrine, skeletal system (In particular, hypotension, orthostatic hypotension, Parkinson's disease, epilepsy, headache or migraine), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs or of constituting a risk whentaking the study medication or interfering with the interpretation of data; 3) Have a history of drug abuse in the past 5 years, or have taken hard or soft drugs in recent 3 monthes; 4) Who have specific allergy history (Such as atopic dermatitis, asthma, etc.) or have known allergies to compounds related to benzoic acid alogliptin tablet and Nesina or multiple drug allergies or known allergic to biologics; 5) Any drug that may affect this study, or is being used by any drug; 6) Before the test within 2 weeks taking special diet (including dragon fruit, mango, grapefruit, and / or xanthine diet) or strenuous exercise, or other effects of drug absorption, distribution, metabolism and excretion of factors. Chocolate, caffeine containing coffee or tea, or any of the caffeine containing foods or beverages within 48 hours before the test; 7) Are unwilling or unable to comply with dietary requirements/restrictions during the study, including eating only the meals provided during theinpatient stays at the CRU; 8) Within three months before the test regular drinkers, weekly drinking more than 14 units of alcohol (1 unit = 3.6 mL beer or 45 ml alcohol for 40% of the spirits or 150 ml wine); 9) Consume more than 5 cigarettes per day or the equivalent within three months before the test; 10) Nearly a year as subjects participated in more than 3 drug clinical trials; participate in the first 3 months before the trial as a subject to participate in any drug clinical trials, or 3 months had more than 400mL blood donors; 11) Known active hepatitis B, HIV, HCV virus and syphilis infection; 12) The subjects did not take effective contraceptive measures or have a birth plan within half a year, or the female subjects were positive for pregnancy test; 13) In the opinion of the investigator or Sponsor, are unsuitable for inclusion in the study; 14) Are investigator site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted; 15) The subjects who may not be possible to complete this study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC 0-t;AUC 0-8; | — |
Countries
China
Contacts
Public ContactYanhua Ding
First Hospital of Jilin University
Outcome results
None listed