Pharmacokinetics and Bioequivalence Study in Human
Conditions
Interventions
1:Phase I: metoprolol succinate sustained-release tablets 47.5mg(Guangxi Houde da Health Industry Co., Ltd)
Phase II: metoprolol succinate sustained-release tablets 47.5mg (astrazeneca pharmaceutical co ltd)
2:Phase I: metoprolol succinate sustained-release tablets 47.5mg(astrazeneca pharmaceutical co ltd)
Phase II: metoprolol succinate sustained-release tablets 47.5mg (Guangxi Houde da Health Industry Co., Ltd)
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The following criteria must be met: 1) Gender: in healthy subjects should have appropriate sex ratio, agreed to during the test and after test does not occur within three months of unprotected sex, contraception and during the test have to take physical ways; Women must meet the following conditions: surgery sterilization; Or fertility, but no clinical significance was found in the pregnancy test results of pretreatment of blood pregnancy (pb-hcg); 2) aged over 18 years old; 3) weight: male body weight is greater than 50 kg, female body weight is greater than 45 kg, body mass index (BMI) is between 19 and 26kg/m2 (BMI= weight (kg)/height 2 (m2)), including boundary value; 4) voluntary signed informed consent.
Exclusion criteria
Exclusion criteria: Subject to one or more of the following criteria: 1) intentional cardiovascular system, endocrine system, nervous system disease or lung, hematology, immunology, psychiatric disease, metabolic abnormalities, such as history of serious illness or have orthostatic hypotension, treatment or faint at the sight of puppy blood, or disease likely to interfere with the test results (inquiry); 2) allergy to this product or other angiotensin converting enzyme inhibitor or allergic constitution (preliminary); 3) underwent surgery within 6 months prior to the trial (preliminary); 4) the drug users were used within 2 weeks before the test, but the time of drug cleaning was reached by the researchers, with the exception of those who had not interfered with the test (preliminary); 5) liver drug enzyme inhibitors or inducers were used within 30 days before the test (preliminary); 6) participated in any other clinical trial within 3 months prior to the trial (preliminary); 7) in the past three months, a family planning person (preliminary); 8) unable to adhere to a unified diet due to food allergies or special dietary requirements (preliminary); 9) have had difficulty in swallowing, peptic ulcer or any gastrointestinal system disease and affect the medical history of drug absorption, and now feel that the digestive tract is not well (preliminary); 10) in the first 3 months of the trial, the blood donation/blood loss reached 400ml and the above, except for the female menstrual blood loss (preliminary); 11) drink excessive amounts of tea, coffee or caffeinated beverages (8 cups or more, 200mL per cup) per day; (preliminary); 12) smoking more than 5 persons per day in the first 3 months of the trial (preliminary); 13) experiment six months before or during the frequent drinkers, that drinking more than 14 units of alcohol a week (14 units = 8 bottles of beer (a bottle of 500 ml, alcohol to 3.5%) or 0.5 jin liquor (quantity in 45% alcohol) or 1.5 bottles of wine (750 ml bottle of alcohol to 13%))(preliminary); 14) drug users were used within 1 year before the test (preliminary); 15) women in lactation or pregnancy (preliminary); 16) high serum potassium (serum potassium >5.3mmol/L); 17) the systolic pressure is greater than or equal to 140mmHg or the diastolic pressure is greater than 90mmHg; 18) systolic pressure < 90mmHg or diastolic pressure < 60mmHg; 19) the laboratory examination (blood routine, urine routine, liver and kidney function, serum electrolyte) was found in the first week before the test; 20) pre-test physical examination, electrocardiogram or vital signs with clinical significance; 21) hepatitis b surface antigen, hepatitis c virus antibody, human immunodeficiency virus antibody antigen test, and treponema pallidum antibody test have clinical significance; 22) the results of pregnancy test have clinical significance; 23) alcohol breath test positive; 24) drug screening test positive; 25) the researcher believes that there are other persons who are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| bioequivalence; | — |
Countries
China
Contacts
Public ContactPeng Wenxing
The Second Xiangya Hospital of Central South University
Outcome results
None listed