Type 2 diabetes
Conditions
Interventions
fasting congdition(pre-test):After fasting overnight for at least 10 hours, one tablet of the test preparation or one tablet of the reference preparation was taken with 240mL 20% glucose solution on
fasting congdition:After fasting overnight for at least 10 hours, one tablet of the test preparation or one tablet of the reference preparation was taken with 240mL 20% glucose solution on an empty st
fed condtion:After fasting overnight for at least 10 hours, eat a high-fat and high-calorie standard meal 30 minutes before taking 1 test preparation or the reference preparation with 240mL of normal
Sponsors
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects aged 18 years and above; 2. Male subjects were not less than 50 kg in weight and female subjects were not less than 45 kg in weight; body mass index (BMI)= body weight (kg)/ height 2(m2) in the range of 19-26 kg/m2; 3. Voluntarily sign informed consent after being informed of the full content of the consent; 4. Be able to follow the research plan to complete the test. Those who do not meet one of the above conditions shall not be selected as qualified subjects.
Exclusion criteria
Exclusion criteria: (1) Clinically significant abnormalities, or diseases such as heart, liver, kidney, digestive tract, endocrine, blood system, respiratory system, nervous system and mental disorders; (2) History of drug or food allergy or are known to be allergic to the study of active ingredients or accessories; (3) Lactose intolerance or malabsorption, or suffering from a disease affecting lactose absorption; (4) With difficulty in venous blood collection; (5)History of halo needle or blood halo; (6) History of dysphagia or any gastrointestinal disease affecting drug absorption; (7) HIV antibody positive, syphilis and hepatitis positive; (8) Subjects (including male subjects) have a family plan from 2 weeks before screening to 3 months after the last administration of the study drug and are unable to take effective contraception; (9) The female subjects were tested positive for breast-feeding, pregnancy or pregnancy during screening or testing; (10) History of alcohol abuse or moderate drinkers in the last 2 years; (11) Smoked more than 5 cigarettes per day in the first three months; (12) History of drug abuse and have a positive urine drug screening; (13) Take any alcohol-containing product 48 hours before taking the research medication; (14) Undergone surgery within 3 months prior to the administration of the drug or who plan to undergo surgery during the trial period; (15) To participate in any clinical drug trial as a subject within 3 months prior to administration; (16) Blood or massive bleeding (>450 mL) was presented within 3 months prior to administration; (17) Take any prescription, over-the-counter, functional vitamins, health products or herbal medicines within 14 days prior to administration; (18) Have special requirements for diet and are not subject to a uniform diet; (19) Any food or drink containing caffeine or rich in xanthine, such as coffee, strong tea, chocolate, coke, etc., within 48 hours prior to taking the study drug; (20) Have eaten fruit or related products affecting metabolic enzymes such as grapes, grapefruit, dragon fruit and mango within 7 days prior to taking research drugs; (21) Use of any drugs that inhibit or induce the liver's metabolism within 30 days prior to the test; (22) The researchers believe that there is anything that might affect the subject's informed consent or compliance with the test protocol, or that the subject participation in the trial may affect the results of the trial or the safety of the subjects themselves.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactWenping Wang
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Outcome results
None listed