Hypertension
Conditions
Interventions
experiment group:allisartan 480mg
control group:placebo
Sponsors
Zhejiang provincial People's Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. The object who signed the informed consent before the test and fully understood the test content, process and possible adverse reactions; 2. The subjects who can complete the study according to the requirements of the test scheme; 3. Subjects (including partners) are willing to voluntarily take effective contraceptive measures within 6 months from screening to the last study drug administration. See Appendix for specific contraceptive measures; 4. Male and female subjects aged 18-55 (including 18 and 55 years old); 5. The body weight of male subjects is no less than 50kg, and that of female subjects is no less than 45kg; body mass index (BMI) = body weight (kg) / height 2 (M2), body mass index is in the range of 19-26kg / m2 (including the critical value); 6. Physical examination and vital signs are normal or abnormal without clinical significance; systolic blood pressure > 100 and = 60 and < 90mmHg, without postural hypotension.
Exclusion criteria
Exclusion criteria: Main exclusion criteria 1. The subjects who smoked more than 5 cigarettes per day in the three months before the experiment and could not guarantee to quit smoking during the experiment; 2. Those who are known or suspected to have allergic reactions to angiotensin-II receptor antagonists such as alisartan ester and accessories of the product; or allergic constitution (multiple drugs and food allergy); 3. Subjects with a history of drug and / or alcohol abuse (14 units of alcohol per week: 1 unit = 285 ml of beer, or 25 ml of spirits, or 100 ml of wine); 4. Blood donation or massive blood loss within three months before screening (> 450 ml); 5. The subjects who took any drug that changed the activity of liver enzyme 28 days before screening; the following inhibitors or inducers of CYP3A4, P-gp or BCRP, such as itraconazole, ketoconazole or dronedarone, etc.; 6. Subjects who took any prescription medicine, over-the-counter medicine, any vitamin product or herbal medicine within 14 days before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;Tmax;t1/2;?z;AUC0-72;AUC0- 8;Vz/F;CL/F;Tmax,ss;Cmax,ss;Cmin,ss;t1/2,ss;Adverse events; | — |
Countries
China
Contacts
Public ContactYing Wang
Zhejiang provincial People's Hospital
Outcome results
None listed