Type 2 diabetes
Conditions
Interventions
Experimental group (fasting):Taking investigational drugs
Control group (fasting):Taking reference medication
Experimental group (after meals):Taking investigational drugs
Control group (after meals):Taking reference medication
Sponsors
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Fully understand the purpose, nature, methods of the trial, as well as the possible adverse reactions, and voluntarily participate as a subject. Sign the informed consent form by oneself before any research procedure begins. 2) Healthy male or female subjects aged 18 years or older. 3) Male weight >= 50.0 kg, female weight >= 45.0 kg; body mass index (BMI) within the range of 19.0 - 26.0 kg/m2 (including the critical value). 4) Physical examination, physical assessment, clinical laboratory tests (blood routine test, urine dry chemical + urine sediment quantitative test, blood biochemical test, infection eight-item test, coagulation four-item test, blood pregnancy test (only for females)), alcohol breath test, drug abuse screening, 12-lead electrocardiogram test results judged by the research doctor as normal or with no clinical significance. 5) Within 3 months after signing the informed consent form, there is no pregnancy plan and voluntarily take effective contraceptive measures (Appendix 2), and no sperm donation or egg donation plans. 6) Able to communicate well with the researcher and be able to understand and comply with all requirements of this study.
Exclusion criteria
Exclusion criteria: 1) Allergy, such as a known history of allergy to two or more substances, or a known history of allergy to ligagliptin tablets or its excipients, a history of hypersensitivity reactions such as rapid allergic reactions, exfoliative dermatitis, urticaria, angioedema, etc. 2) Have difficulty swallowing or have any history of gastrointestinal diseases that affect drug absorption or increase drug safety risk (such as chronic diarrhea, Barrett's esophagus, other esophageal diseases, gastritis, duodenitis, peptic ulcer, etc.); 3) Have any history of chronic or serious diseases of the blood circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, mental or metabolic disorders, or have experienced any other diseases that the investigator judges may affect drug absorption, distribution, metabolism, excretion, or interfere with the test results; 4) Patients with a history of pancreatitis or a history of hypoglycemia, heart failure and renal function injury; 5) Those who had undergone surgery within 6 months prior to the trial that the investigator determined would affect drug absorption, distribution, metabolism, or excretion, or planned to undergo surgery between the study period and 1 week after the study; 6) Poor vascular puncture conditions, or can not tolerate venous puncture, or have a history of fainting needle and fainting blood; 7) Those who have a history of drug abuse in the six months prior to screening, or who have used drugs in the three months prior to screening, including repeated and heavy use of narcotic drugs and psychotropic substances for non-medical purposes, Or urine addictive drugs morphine, methamphetamine (methamphetamine), ketamine, dimethylene dioxyamphetamine (ecstasy), tetrahydrocannabinol (cannabis) screening test any one or more positive results; 8) Participants who have participated in or are participating in other drug clinical trials within 3 months before screening, or have used drugs related to this trial; 9) Blood donation including blood components or massive blood loss (>=400mL) (excluding physiological blood loss in women), transfusion or use of blood products within 3 months before screening; Or those who plan to donate blood (including blood components) during or within 3 months after the trial; 10) The woman is pregnant, breastfeeding, or the woman has unprotected sex or a positive blood pregnancy test within 14 days before the planned drug administration; 11) Women who used oral contraceptives within 30 days before the trial; 12) Women who use long-acting estrogen or progesterone injections (including progesterone IUD) or implants within 6 months before the trial; 13) People who have used any prescription drugs, over-the-counter drugs, Chinese herbs, health products and vitamins within 14 days before screening; 14) Those who received vaccination within 4 weeks prior to the trial, or who plan to receive vaccination during the trial; 15) Smokers who smoked more than 5 cigarettes per day in the 3 months prior to screening, or who could not stop using any tobacco products, including any smoking cessation products containing nicotine, within 48 hours prior to the first dose and throughout the trial period; 16) Those who consumed an average of more than 14 units of alcohol per week in the 3 months prior to screening (1 unit =360mL beer or 45mL liquor with 40% alcohol or 150mL wine), or who could not abstinence within 48h prior to first adminis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-72h;Cmax; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;?z;t1/2; | — |
Countries
China
Contacts
Public ContactYang Hui
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Outcome results
None listed