Essential hypertension
Conditions
Interventions
Sponsors
Huzhou Central Hospital, Zhejiang Province
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Fully understand the content of the informed consent form and sign it voluntarily, and voluntarily participate in the trial; 2) Subjects can communicate well with the investigator, sign the informed consent form before screening, fully understand the content, process and possible adverse reactions of the trial, and be able to complete the study in accordance with the requirements of the trial protocol. 3) Participants are willing to have no pregnancy plan and voluntarily take effective contraceptive measures within 6 months from the screening date to the end of the trial; 4) male or female healthy subjects over the age of 18 (including 18 years of age); 5) Male subjects weighed at least 50 kg and female subjects weighed at least 45 kg. Body mass index (BMI) = body weight (kg) / height 2 (m2), body mass index in the range of 19.0~26.0kg/m2 (including critical value).
Exclusion criteria
Exclusion criteria: 1) Those who have a history of specific allergies (asthma, urticaria, eczema, etc.), or allergic constitution (such as those who are allergic to drugs, food such as milk and pollen), or those who are known to be allergic to the components of this drug or analogues; 2) Those with any disease that increases the risk of bleeding, such as acute gastritis or active ulcer with bleeding, clinically significant thrombocytopenia or anemia, and those with active pathological bleeding or a history of intracranial hemorrhage; 3) People with dysphagia or any history of gastrointestinal diseases that affect drug absorption; 4) Diseases with abnormal clinical manifestations that need to be excluded before screening or in progress, including but not limited to sodium and blood volume reduction, hypotension, heart failure and myocardial infarction, aortic valve and mitral valve stenosis and obstructive myocardial hypertrophy, Liver and kidney dysfunction, biliary obstructive disease, renal artery stenosis, kidney transplantation, hyperkalemia, angioedema, and other respiratory systems, circulatory system, digestive system, blood system, endocrine system, immune system, skin system, mental Nervous system, ENT and other related diseases; 5) Abnormalities in physical examination, electrocardiogram, vital signs and laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function, pregnancy test (only for women), infectious disease screening) have clinical significance within 14 days before taking the study drug (subject to the judgment of the clinician); 6) Those who have undergone major surgery within 6 months before taking the study drug; 7) Those who have used drugs within 3 months before screening, or have a history of drug abuse within 12 months before screening, or those who have a positive urine drug screen; 8) Those who smoked more than 5 cigarettes a day within 3 months before screening, or who could not stop the intake of any tobacco products during the study; 9) Regular drinkers within 3 months before screening, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer with 5% alcohol content or 45 mL of spirits with 40% alcohol content or 150 mL of alcohol 12% wine), or alcohol breath test results > 0mg/100mL, or those who could not stop alcohol intake during the study; 10) Those who donated blood including component blood or massive blood loss (=400mL), received blood transfusion or used blood products within 3 months before screening; 11) Taking any changes in the gastrointestinal environment within 30 days before taking the study drug (such as proton pump inhibitor tetuprazole, omeprazole, lansoprazole, esoprazole, etc.; H2 antagonist ranitib Ding, cimetidine, famotidine, etc.; antacids sodium bicarbonate, magnesium oxide, aluminum hydroxide, magnesium trisilicate, etc.; gastric mucosal protective agent sucralfate, etc.) or drugs that change the activity of liver enzymes ( Such as: inducers - barbiturates, carbamazepine, phenytoin, dexamethasone, etc.; inhibitors - SSRI antidepressants, ciprofloxacin, cimetidine, diltiazem, macrolides, formazan Nitazole, ketoconazole, verapamil, fluoroquinolones, omeprazole, etc.); 12. Taking drugs that interact with this product within 30 days before taking the study drug, including but not limited to lithium, potassium-sparing diuretics (such as: spironolactone, triamterene, etc.), angiotensin-converting enzyme inhibitors Drugs (such as: captopril, enalapril,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;t1/2;AUC_%Extrap;?z; | — |
Countries
China
Contacts
Public ContactYang Shuixin
Huzhou Central Hospital, Zhejiang Province
Outcome results
None listed