Pharmacokinetics and Bioequivalence Study in Human
Conditions
Interventions
T-R (Fasting):The subjects shall be orally given the test preparation 47.5mg Metoprolol succinate sustained release tablets produced by Guangxi Houde Great Health Industry Co., LTD in the first cycle
R-T (Fasting):Subjects will be given the reference preparation of 47.5mg Metoprolol succinate sustained release tablets produced by Astrazeneca in the first cycle orally on an fasting stomach. In the
T-R (Postprandial):The subjects were given 47.5mg metoprolol succinate sustained release tablets produced by Guangxi Hou De Great Health Industry Co., LTD in the first cycle when they started to eat a
R-T (Postprandial):Subjects were given 47.5mg of Metoprolol succinate sustained release tablets produced by Astrazeneca in the first cycle after 30min of high-fat diet. In the second cycle, the tested
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Age =18, male or female; 2) Male subjects should be at least 50kg in weight, female subjects should be at least 45kg in weight, and body mass index (BMI) should be between 19 and 26kg/m2, including boundary values; 3) Subjects must give informed consent to this study before the experiment, and voluntarily sign written informed consent.
Exclusion criteria
Exclusion criteria: 1) Have or currently have circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunity Any clinically serious disease, such as scientific, psychiatric and metabolic disorders, or diseases that may interfere with the test results; 2) It is clear that the person is allergic to the drug or its preparation ingredients; 3) Patients who had undergone surgery within 4 weeks before the trial; 4) Patients who have used any drug (including Chinese herbal medicine) within 14 days before the test, except those who have not interfered with the test, but have reached the drug cleaning time as determined by the researcher; 5) Any drug that inhibits or induces liver metabolism of drugs (e.g., inducers -- barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole) used within 30 days before the test; Inhibitors -- SSris antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines); 6) Participants in clinical trials of any other drug within 3 months prior to the trial; 7) Blood donors within 3 months before the test; 8) Lactating women, or subjects who plan to have children within three months; 9) Those who cannot follow a uniform diet; 10) Excessive consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =200mL) per day; 11) Smokers or smokers who smoked more than 5 cigarettes a day on average in the 3 months before the trial; 12) Heavy drinkers or regular drinkers in the 6 months prior to the trial, i.e. drinking an average of more than 14 units of alcohol per week (14 units =8 bottles of beer (500ml each with 3.5% alcohol content) or 0.5 kg of white wine (45% alcohol content) or 1.5 bottles of wine (750ml each with 13% alcohol content); 13) Drug abusers or those who have used soft drugs (e.g., cannabis) in the 3 months prior to the trial or hard drugs (e.g., cocaine, PCP, etc.) in the 1 year prior to the trial; 14) Patients with clinically significant abnormal vital signs before the trial; 15) Abnormal physical examination before the test has clinical significance; 16) Patients with abnormal electrocardiogram before the test had clinical significance; 17) Abnormal laboratory examinations (blood routine, urine routine, liver and kidney function, coagulation function, thyroid function, serum electrolyte) before the test have clinical significance; 18) Hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody antigen, treponema pallidum antibody have clinical significance; 19) Pregnancy examination results have clinical significance (female only); 20) Positive in drug screening; 21) Subjects who may not be able to complete the study for other reasons or who the investigator believes should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The blood concentration of metoprolol;Peak concentration;AUC0-8 (Area under curve from drug administration to time extrapolated to infinity);AUC0-t; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach peak concentration;Apparent terminal elimination rate constant;t1/2;CL/F; | — |
Countries
China
Contacts
Public ContactPeng Wenxing
The Second Xiangya Hospital of Central South University
Outcome results
None listed