Adult primary hypertension
Conditions
Interventions
A group:First cycle, Measartan Potassium Tablets (Shandong New Era Pharmaceutical Co., Ltd.), washout period 7 days
second cycle, Measartan Potassium Tablets (Manufacturer: Takeda Ireland Ltd.)
B group:First cycle, Azilsartan potassium tablets (manufacturer: Takeda Ireland Ltd.), washout period 7 days, second cycle, Azilsartan potassium tablets (Shandong New Era Pharmaceutical Co., Ltd.)
Sponsors
The Second Affiliated Hospital Of Xingtai Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Individuals who voluntarily participate and sign the informed consent form; 2. Healthy male and female study participants aged 18–65 years (including 18 and 65); 3. Male participants weighing >=50.0 kg, female participants weighing >=45.0 kg. Body Mass Index (BMI) = weight (kg)/height^2(m^2), with a BMI between 19.0–26.0 kg/m^2, inclusive of the boundary values; 4. Study participants (including their partners) must ensure that they have no plans for conception from 2 weeks prior to screening until 3 months after the last administration, and voluntarily use appropriate contraception.
Exclusion criteria
Exclusion criteria: 1. Those who have any history of chronic or serious diseases and treatment of the endocrine system, urinary system, digestive system, blood and lymphatic system, respiratory system, cardiovascular system, nervous system, mental illness, musculoskeletal system and other systems and the study doctor judges that the abnormality is clinically significant, pay special attention to ischemic cardiomyopathy, ischemic cerebrovascular disease, severe liver function injury, aortic or mitral valve stenosis or hypertrophic obstructive cardiomyopathy, renal function damage and renal artery stenosis, hypotension or dizziness in the morning and other diseases; 2. Physical examination, vital sign examination, clinical laboratory examination (including blood routine, blood biochemistry, urine routine, coagulation function test), 12-lead electrocardiogram examination, the results show abnormal clinical significance; 3. Known history of allergy to mesartan potassium tablets or any drug component or similar drugs; Those with a specific history of allergies (asthma, allergic rhinitis, eczema, etc.); Those who have a history of allergy to two or more drugs, foods, etc.; Those who belong to allergies; 4. Those who have difficulty swallowing tablets; 5. Those who have special requirements for diet and cannot accept a unified diet; 6. Those who are lactose intolerant (those who have had diarrhea after drinking milk); 7. Those who cannot tolerate venipuncture and have a history of needle sickness; 8. Clinically significant abnormalities in any of the serum virology examinations; 9. Excessive alcohol consumption within 3 months before screening, that is, drinking more than 14 units of alcohol per week (1 unit = 360mL beer or 45mL of spirits with 40% alcohol content or 150mL wine); or have taken any alcohol-containing products within 48 hours before administration, or those who have an alcohol breath test result > 0mg/100mL; or those who cannot stop drinking during the trial; 10. Those who smoke = 5 cigarettes per day within 3 months before screening or cannot stop using any tobacco products during the trial; 11. Those who have donated blood or lost a large amount of blood (>400mL), received blood transfusion or used blood products within 3 months before screening; 12. Participated in any clinical trial within the past 3 months before screening; 13. Underwent surgery within 30 days before screening, planned to undergo surgery during the study, or had surgery that could affect drug absorption, distribution, metabolism, or excretion; 14. Taken any prescription drugs, over-the-counter medications, health supplements, vitamins, or Chinese herbal medicine within 14 days before screening; 15. Received any vaccination within 1 month before screening; 16. Used any drugs within 30 days before screening that interact with Measartan Potassium Tablets (such as ACE inhibitors) or alter liver enzyme activity (such as terfenadine, astemizole) or drugs with a long half-life; 17. Consumed excessive tea, coffee, or beverages containing caffeine, grapefruit, or pomelo within 3 months before screening (more than 8 cups per day, 1 cup = 250 mL); or consumed any tea, coffee, and/or beverages or foods containing caffeine, grapefruit, or pomelo within 48 hours before dosing; or cannot stop consuming them during the trial; 18. Female participants who are breastfeeding or have a positive pregnancy test; 19. History of drug abuse or positive urine drug screening; 20. Developed an acute illne
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-8;AUC0-t;Cmax; | — |
Countries
China
Contacts
Public ContactFengxue Guo
The Second Affiliated Hospital Of Xingtai Medical College
Outcome results
None listed