High blood pressure
Conditions
Interventions
10mg (group 1):10mg MT-1207 Tablets/5mg Amlodipine Besylate Tablets/vehicle, 10 days.
20mg (group 2):20mg MT-1207 Tablets/5mg Amlodipine Besylate Tablets/vehicle, 10 days.
40mg (group 3):40mg MT-1207 Tablets/5mg Amlodipine Besylate Tablets/vehicle, 10 days.
60mg (group 4):60mg MT-1207 Tablets/5mg Amlodipine Besylate Tablets/vehicle, 10 days.
5mg (group 5):5mg MT-1207 Tablets/5mg Amlodipine Besylate Tablets/vehicle, 10 days.
90mg (group 6):90mg MT-1207 Tablets/vehicle
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent before the test, and fully understand the test content, process and possible adverse reactions, be able to complete the study according to the requirements of the test program; 2. Subjects (including partners) are willing to voluntarily take effective contraceptive measures within 6 months after screening to the last study drug administration; 3. Male and female subjects aged between 18 and 65 years (including 18 and 65 years); 4. Body mass index (BMI) = weight (kg)/height 2 (m2: 18~30kg/m2 (including the critical value); 5. Patients with primary mild to moderate hypertension who are not treated with antihypertensive drugs, the resting sitting blood pressure 140mmHg <= SBP < 180mmHg and 90mmHg <= DBP < 110mmHg.
Exclusion criteria
Exclusion criteria: 1. Those who smoked more than 5 cigarettes a day on average in the 3 months before the test; 2. Allergies (multiple drugs and food allergies); 3. Donate blood or lose a lot of blood ( > 450 mL) within 3 months before screening; 4. A history of alcohol abuse (alcoholism is defined as: drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); history of drug abuse or drug use in the past five years By; 5. Female subjects are breastfeeding or have a positive serum pregnancy result during the screening period or the test process; 6. 12-ECG abnormalities have clinical significance (such as atrioventricular block of degree II and above, sick sinus syndrome, other malignant or potentially malignant arrhythmias, or abnormalities judged by clinicians to have other clinical significance); 7. Known or suspected secondary hypertension, including but not limited to bilateral renal artery stenosis, primary aldosteronism, pheocytoma, cystic nephropathy, drug-induced hypertension, etc.; 8. Acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, cerebrovascular accident occurred within 6 months; 9. Except for hypertension itself, there is any history of serious diseases, or medical history that the investigator thinks may affect the test results, including but not limited to the circulatory system (such as NYHAI I~IV heart failure, aortic stenosis, aortic aneurysm or dissection Tumor, etc.), endocrine system, nervous system, digestive system, urinary system or blood, immune, mental and metabolic disease history; 10. There are malignant tumors within 5 years before signing the informed consent (except for specific cancers that are surgically removed and completely cured [except for basal cell carcinoma of the skin or squamous cell carcinoma, etc.] or carcinoma in situ of the cervix); 11. Take strong inhibitors and/or inducers of liver metabolic enzymes and any drugs metabolized by CYP2D6 within 28 days before screening; 12. Take any prescription drugs, non-prescription drugs, any vitamin products or Chinese herbal medicines within 14 days before screening; 13. In the 14 days before screening, you have taken food that affects metabolism, such as grapefruit or drinks containing grapefruit, or performed high-intensity physical exercises (such as: strength training, aerobic training, and football), or there are other drugs that affect the absorption , Distribution, metabolism, excretion and other factors; 14. Dangerous operators such as ship erection and high-altitude operations; 15. Participated in any drug or medical device and other clinical trials within 3 months before screening; 16. ALT and/or AST > 1.5 x upline of normal value (ULN); blood creatinine > 1.5 x ULN; or any clinically significant laboratory abnormality that the researcher thinks may affect this test; 17. Type 1 diabetes and type 2 diabetes with poor blood sugar control (HbA1c >= 8%); 18. Those who are positive for any of hepatitis B surface antigen, hepatitis C antibody, hepatitis C core antigen, AIDS antibody, and Treponema pallidum antibody, and those who are positive for Treponema pallidum antibody, need the rapid plasma reagin test (RPR) test, if RPR is positive at the same time , need to be excluded; 19. Have taken any alcohol-containing products or a positive alcohol breath test within 72 hours before the first medication; 20. Those who have a positive urine drug screen; 21. The investigat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerance indicators;Pharmacokinetic indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic indicators; | — |
Countries
China
Contacts
Public ContactWang peng
Outcome results
None listed