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. Gender: male and female subjects; 2. Age: 18 years old or above (including 18 years old); 3. Weight: male subjects should not be less than 50.0 kg, female subjects should not be less than 45.0 kg, body mass refers to The number [BMI = weight (kg) / height 2 (m2)] is in the range of 19.0~26.0 kg/m2 (including boundary values); 4. Those who have been proved to be healthy by medical history, full physical examination and laboratory examination; 5. Those who voluntarily participate and sign the informed consent form; 6. The subject can communicate well with the investigator, and understands and complies with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Abnormal in vital signs, physical examination, blood routine, blood biochemistry, coagulation test, urine routine, 12-lead ECG, hepatitis B surface antigen, hepatitis C antibody, treponemal antibody, AIDS antibody test and determined by the investigator to have clinical significance; 2. Have a history of chronic or serious diseases such as digestive system, endocrine and metabolic system, cardiovascular and cerebrovascular system, nervous system, blood system, urinary system and autoimmune system, or existing diseases of the above systems, and are judged by the investigator to be unsuitable for enrollment; 3. Those with a history of orthostatic hypotension, or those with systolic blood pressure less than 100 mmHg, or diastolic blood pressure less than 60mmHg; 4. Those with a history of mental illness, substance abuse, or drug dependence; 5. Those who have special requirements for diet and cannot comply with the unified diet; or those with dysphagia; 6. Allergies, such as allergies to two or more drugs or foods; or known to be allergic to this product and any auxiliary ingredients; 7. Screening those who drank too much (an average of more than 8 cups a day, 1 cup = 250 mL) tea, coffee or caffeinated beverages within 3 months before screening; or within 48 hours before administration, take tea or any food or drink containing caffeine (such as coffee, chocolate, etc.); 8. Those who consume a large amount of grapefruit-rich beverages or foods (such as grapefruit, grapefruit juice, grapefruit jam, etc.) within 14 days before screening; or those who have ingested any grapefruit-rich beverage or food within 48 hours before administration; 9. Those who cannot tolerate intravenous indwelling needle blood collection or needle sickness or blood sickness; 10. Those who consumed an average of more than 14 standard units per week in the 3 months prior to screening, (1 standard unit containing 14g of alcohol, such as 360 mL of beer or 45 mL of spirits with 40% alcohol volume or 150 mL of wine); Those who have a positive alcohol test result on the day of check-in; 11. Average daily smoking = 5 in the 3 months before screening; 12. Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines and health supplements within 14 days before screening; 13. Those who have participated in other clinical trials within 3 months before screening; 14. Those who have a history of blood donation or heavy bleeding (> 400 mL) within 3 months before screening; 15. Those who have been vaccinated within 1 month before screening or have vaccination plans between screening and the trial period; 16. Those who tested positive for drug abuse screening (morphine, THC, methamphetamine, methylenedioxyamphetamine, ketamine, cocaine) on the day of check-in; 17. Pregnant or lactating women, male subjects (or their partners) or female subjects who have a fertility plan throughout the trial period and within 3 months after the end of the study, and are unwilling to use one or more non-pharmacological contraceptive methods (such as complete abstinence, condoms, sterilization, etc.) during the study; 18. Subjects deemed unsuitable for enrollment for other reasons by the investigator.
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