healthy subjects
Conditions
Interventions
Fast T-R group:In the fasting state, one tablet of test preparation was taken orally in the first period and one tablet of reference preparation was taken orally in the second period
Fast R-T group:In the fasting state, one tablet of reference preparation was taken orally in the first period and one tablet of test preparation was taken orally in the second period
Fed T-R group:In the postprandial state, one tablet of test preparation was taken orally in the first period and one tablet of reference preparation was taken orally in the second period
Fed R-T group:In the postprandial state, one tablet of reference preparation was taken orally in the first period and one tablet of test preparation was taken orally in the second period
Sponsors
Huzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subject fully understands the purpose, nature, method and possible adverse reactions of the study, voluntarily acts as a subject, and signs informed consent prior to the start of any test procedure; 2. Male or female healthy subjects above the age of 18 (including 18 years old); Male weight =50.0 kg, female weight =45.0 kg; Body mass index (BMI) was in the range of 19.0~26.0 kg/m2 (including the critical value), body mass index (BMI) = weight (kg)/height 2 (m2); 3. The subjects were able to communicate well with the researchers and understood and complied with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. People with a history of specific allergies (such as asthma, urticaria, eczema, etc.), or allergic conditions (such as allergy to two or more drugs, foods such as milk and pollen), or known allergy to metformin, or englazine, or any excipients of this product; 2. Patients with a history of diabetes, hypoglycemia or hypotension, or who will receive intravascular iodized contrast media; 3. Patients who have developed or are developing clinically significant (subject to the doctor's judgment) diseases that need to be excluded before screening, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal system, respiratory system, metabolism and bone system; 4. A history of dysphagia or any gastrointestinal disease that affects drug absorption (such as inflammatory bowel disease, gastritis, ulcers, colitis, rectal bleeding, persistent nausea, or other gastrointestinal abnormalities); 5. Those who had undergone surgery prior to screening that was determined by the study physician to affect drug absorption, distribution, metabolism and excretion, or who planned to undergo surgery during the study period; 6. Vital signs examination, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemistry, blood transfusion, coagulation function), pregnancy test (female), 12-lead electrocardiogram examination judged by the researcher abnormal clinical significance; 7. Female subjects had pregnancy plans, were unwilling to take effective contraceptive measures (see Protocol Appendix 1) or had sperm donors for male subjects and egg donors for female subjects from 2 weeks before screening (after the first dose for male subjects) to 3 months after the last dose of study drug; 8. Patients who cannot tolerate venipunction, patients with difficulty in blood collection, patients with blood fainting and patients with needle fainting; 9. People who are lactose intolerant (have experienced diarrhea from drinking milk) or cannot tolerate 20% glucose solution; 10. Persons who have used drugs or have a history of drug abuse in the 12 months prior to screening; 11. Participants who have participated in other drug clinical studies and taken study drugs within 3 months prior to screening; 12. People who donated blood including component blood or substantial blood loss (> 200mL) within the 3 months prior to screening, received blood transfusions or used blood products, or planned to donate blood within one month of the end of the study, or during the study period (from the screening date to the end of the study); 13. People who have taken any drugs that alter the gastrointestinal environment (e.g., proton pump inhibitors Tetorazole, prilosec, lansoprazole, esoprazole, etc.) within 30 days prior to screening; H2 antagonists ranitidine, cimetidine, famotidine, etc. Antacid sodium bicarbonate, magnesium oxide, aluminum hydroxide, magnesium trisilicate, etc. Thiocarcinoaluminum, etc.), or take drugs that interact with this product (such as diuretics, insulin or insulin secretagotropin, renozine, fantanib, dotenavir, zonisamide, acetazolamide, corticosteroids, phenolthiazine, thyroid preparations, estrogen, oral contraceptives, etc.); 14. Use of any prescription, over-the-counter, Chinese herbal and health products in the 2 weeks prior to screening; 15. Persons who received vaccination within 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration;Cmax;AUC0-t;AUC0-8;Tmax;?z;t1/2;AUC_%Extrap; | — |
Countries
China
Contacts
Public ContactYang Shuixin
Huzhou Central Hospital
Outcome results
None listed