None
Conditions
Interventions
Group 1 (fasting):Test preparation - Reference preparation
Group 2 (fasting):Reference preparation - Test preparation
Group 3 (postprandial):Test preparation - Reference preparation
Group 4 (postprandial):Reference preparation - Test preparation
Sponsors
The Second Affiliated Hospital of Xingtai Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) The subjects fully understand the purpose, nature, methods and possible adverse reactions of the experiment, voluntarily participate in the experiment, and sign the informed consent before the experiment begins; 2) Healthy subjects aged 18-55 (including the critical value) have an appropriate sex ratio between men and women; 3) Body mass index (BMI) = weight (kg)/ height 2(m2), and the BMI is in the range of 19.0~26.0 (including the critical value); The weight of male subjects is not less than 50.0 kg, and that of female subjects is not less than 45 kg; 4) The subject has no birth plan within 3 months from the signing of the informed consent form to the end of the study, and agrees that the subject and his/her partner will voluntarily take effective and appropriate contraceptive measures during this period; 5) Subjects can communicate well with researchers and understand and abide by the requirements of this study.
Exclusion criteria
Exclusion criteria: 1) (Inquire) Those who are allergic to metformin, englejing or any auxiliary ingredients of this product; Or people with allergies (such as those who are allergic to two or more drugs and foods); 2) (Inquiry) Diseases or factors with abnormal clinical manifestations that need to be excluded, including but not limited to diseases of nervous system, cardiovascular system, respiratory system, digestive system, metabolism, bone and other systems; There are factors that will endanger the safety of the subjects or other factors that may affect the absorption, distribution, metabolism and excretion of drugs, such as dysphagia and a history of gastrointestinal diseases; 3) (Inquiry) Those who have a history of hypoglycemia, vitamin B12 deficiency, hypotension, genital fungal infection or urinary system infection, acute or chronic metabolic acidosis (including lactic acidosis or ketoacidosis), or patients with liver disease, renal dysfunction, alcoholism or heart failure; (4) (Inquire) those who have undergone iodine contrast within 48 hours before administration or who will receive intravenous injection of iodine contrast during the trial; 5) (Inquiry) Those who have undergone major surgery within 3 months before administration, or plan to have surgery during the trial; 6) (Inquiry) Those who can't tolerate venipuncture and have a history of needle fainting and blood fainting; 7) (Inquiry) Anyone who has a history of drug abuse or used any drugs within 6 months before administration; 8) (Inquiry) Those who have donated blood or lost blood (=200mL), received blood transfusion or used blood products within 3 months before administration; Or plan to donate blood or blood components during the trial; 9) (Inquiry) Subjects have plans to donate sperm and eggs within 3 months from the first medication to the end of the study; 10) (Inquiry) Have used any drugs that inhibit or induce the metabolism of drugs in the liver within 30 days before administration (such as:inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; Inhibitors --SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, verapamil, fluoroquinolones, antihistamines) or any other drugs (including traditional Chinese medicine) that researchers think may affect the evaluation of pharmacokinetic characteristics of the research drugs; 11) (Inquiry) Have used any drugs that interact with metformin (such as ranolazine, Fantanib, Dotiravir, cimetidine, zonisamide, acetazolamide, diclofenac, or thiazides, corticosteroids, phenothiazines, thyroid preparations, estrogens, oral contraceptives, nicotinic acid, sympathomimetic drugs, calcium channel block) 30 days before screening. Those who have used any drugs (such as diuretics, insulin or insulin secretagogue, gemfibrozil, rifampicin, probenecid, etc.) that interact with Engleggin in the first 30 days of screening; 12) (Inquiry) Anyone who has been vaccinated within 30 days before administration; 13) (Inquiry) Those who smoked more than 5 cigarettes a day on average within 30 days before screening; Or there is no guarantee that smokers will stop smoking from signing the informed consent form to the end of the study; 14) (Inquiry) The average alcohol intake in the 30 days before screening exceeded 2 units per day (1 unit =360mL of beer with 5% alcohol content, or 45mL of spirits with 40% alcohol content, or 150mL of wine with 12% alcohol content); Or can't guarantee to stop drinking and alcoholic products from
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t of metformin and englishgin;Cmax of metformin and englishgin;AUC0-8of metformin and englishgin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax of metformin and englishgin; | — |
Countries
China
Contacts
Public ContactGou Fengxue
The Second Affiliated Hospital of Xingtai Medical College
Outcome results
None listed