Essential hypertension in adults
Conditions
Interventions
B Group:Two-period open-label crossover study, with the reference formulation administered in the first period and the test formulation in the second period
A Group:Two-period open-label crossover study, with the test formulation administered in the first period and the reference formulation in the second period
Sponsors
The Second Affiliated Hospital Of Xingtai Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Those who voluntarily participate and sign the informed consent form; 2. Healthy male and female study participants aged 18~65 years (including 18 and 65 years old); 3. Male weight >=50.0kg, female weight >=45.0kg. Body mass index (BMI) = weight (kg)/height^2 (m^2), body mass index between 19.0-26.0kg/m^2, including the cut-off value; 4. Study participants (including partners) guarantee no birth plan and voluntarily take adequate contraceptive measures from 2 weeks before screening to 3 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Individuals with chronic or severe diseases of the endocrine system, urinary system, digestive system, blood and lymphatic system, respiratory system, cardiovascular system, nervous system, mental illness, musculoskeletal system, etc., who are clinically significant according to the research doctor's judgment of abnormalities, should pay special attention to ischemic cardiomyopathy, ischemic cerebrovascular disease, severe liver function injury, aortic or mitral valve stenosis or hypertrophic obstructive cardiomyopathy, renal function injury and renal artery stenosis, hypotension or morning dizziness and other diseases; 2. Physical examination, vital sign examination, clinical laboratory examination (including blood routine, blood biochemistry, urine routine, coagulation function examination), 12 lead electrocardiogram examination, and results showing abnormalities with clinical significance; 3. Known history of allergy to valsartan potassium tablets or any drug components or similar drugs; Individuals with a specific history of allergies (asthma, allergic rhinitis, eczema, etc.); Individuals who have a history of allergies to two or more drugs, foods, etc; Individuals with allergies; 4. Patients with difficulty swallowing tablets; 5. Those who have special dietary requirements and cannot accept a uniform diet; 6. Lactose intolerant individuals (those who have experienced diarrhea from drinking milk); 7. Individuals who cannot tolerate venipuncture and have a history of needle and blood dizziness; 8. Any abnormality in serum virology examination that has clinical significance; 9. Screening for individuals who have consumed excessive amounts of alcohol within the past 3 months, i.e. drinking more than 14 units of alcohol per week (1 unit=360mL of beer or 45mL of 40% spirits or 150mL of wine); Those who have taken any alcoholic products within 48 hours before administration, or whose alcohol breath test results are greater than 0mg/100mL; Or those who cannot stop drinking during the trial period; 10. Individuals who have smoked at least 5 cigarettes per day within the past 3 months or have not stopped using any tobacco products during the trial period; 11. Screening individuals who have donated blood or experienced significant blood loss (>400mL) within the past 3 months, received blood transfusions, or used blood products; 12. Screening participants who have participated in any clinical trials within the previous 3 months; 13. Individuals who have undergone surgical procedures within the 30 days prior to screening, or who plan to undergo surgical procedures during the study period, or who have undergone surgeries that may affect drug absorption, metabolism, distribution, and excretion; 14. Individuals who have taken any prescription drugs, over-the-counter drugs, health supplements, vitamins, or Chinese herbal medicines within the 14 days prior to screening; 15. Screening individuals who have received the vaccine within the previous month; 16. Individuals who have used any drugs that interact with valsartan potassium tablets (such as angiotensin-converting enzyme inhibitors) or alter liver enzyme activity (such as terfenadine, astemizole, etc.) or long half-life drugs within the 30 days prior to screening; 17. Screening for individuals who have consumed excessive amounts of tea, coffee, or beverages containing caffeine, grapefruit, or grapefruit within the past 3 months (8 or more cups per day, 1 cup=250mL); Those who have consumed an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-8;AUC0-t; | — |
Countries
China
Contacts
Public ContactFengxue Guo
The Second Affiliated Hospital Of Xingtai Medical College
Outcome results
None listed