primary hypertension
Conditions
Interventions
Sequence A:In the first and third cycles, the test formulation (T: Sacubitril Arixatam Amlodipine Tablets) was administered
in the second and fourth cycles, the
Sequence B:In the first and third cycles, the reference drug (R: Sacubitril Alesartan Calcium Tablets + Benazepril Hydrochloride Tablets) was administered
in th
Sponsors
The Second Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age of Participants should be in the range of 18 to 60, inclusive, both genders; 2. Weight of participants should be no less than 50 kilograms. Body Mass Index (BMI) = weight (kg) / height^2 (m^2), and the BMI should be within the range of 19 to 26 kg/m^2,inclusive; 3. Participants are able to communicate well with the researchers, fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial, and sign the written informed consent form. 4. Participants or their partners had no plans for pregnancy or sperm donation/egg donation during the study period and within 3 months after the administration of the drug, and must agree to adopt at least one acceptable and effective contraceptive method. 5. During screening period, Participants' blood pressure should meet the following requirements: 110 mmHg <= Sitting Systolic Blood Pressure (SBP) < 140 mmHg, 65 mmHg <= Sitting Diastolic Blood Pressure (DBP) < 90 mmHg, and no orthostatic hypotension.
Exclusion criteria
Exclusion criteria: 1. Those who had an average daily smoking quantity of more than 5 cigarettes for the previous 3 months and were unable to quit smoking during the trial; 2. For pregnant, lactating women, or women of childbearing age participating in the study, the blood pregnancy screening test result was positive; 3. Those who have experienced allergic reactions to losartan potassium, aliskiren, losartan, valsartan (all angiotensin II receptor antagonists), nifedipine, amlodipine (all calcium channel blockers), or their excipients; or those with allergic constitution (allergic to multiple drugs and foods); 4. Individuals who are heavy drinkers or those who have been consuming alcohol frequently within the previous 3 months (i.e., those who consume more than 14 standard units of alcohol per week, where 1 standard unit of alcohol equals 360 mL of beer or 45 mL of 40% alcohol content spirits or 150 mL of wine), or those whose alcohol breath test is positive, or those who cannot stop using any alcoholic products during the test period; 5. Those who have donated blood within the previous three months or have suffered significant blood loss (> 450 mL), have used blood products or have received blood transfusions; 6. History of difficulty in swallowing or any gastrointestinal disease that affects drug absorption; 7. Those with any diseases that increase the risk of bleeding, such as acute gastritis or gastric and duodenal ulcers, etc; 8. Within the 28 days prior to the screening, any medication that alters the activity of liver enzymes (CYP3A4) or inhibitors of transporters (OAT1/3, OATP1B1/3) was taken; 9. Within the 14 days prior to the screening, any prescription drugs, over-the-counter drugs, any vitamin products or herbal remedies were taken; 10. Within the three months prior to taking the study medication, one has taken the study drug or participated in a drug clinical trial and received any other clinical research drugs; 11. Those whose electrocardiogram results were abnormal during the screening and which were determined by the researchers to have clinical significance; 12. During the screening process, if there are any clinically significant abnormalities in the clinical laboratory tests, or if the researchers determine that the participant has other diseases or medical histories that are not suitable for participating in this study, such as those related to the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system, psychiatry, metabolic disorders, gastrointestinal surgeries, etc., they will be excluded from the study; 13. Any one of the following tests being positive: hepatitis B surface antigen test, hepatitis C antibody test, syphilis spirochete specific antibody test, human immunodeficiency virus antibody test; 14. Within 48 hours prior to taking the research drug, the subject consumed chocolate, any food or beverage containing caffeine or rich in xanthine; 15. Participant who has a history of drug use or substance abuse, or the urine drug screening test result was positive during the screening process; 16. There are any other reasons that the researchers consider making the participants ineligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t;Cmax;AUC0-8;AUC0-72h; | — |
Secondary
| Measure | Time frame |
|---|---|
| t1/2;Safety assessment;Tmax;?z; | — |
Countries
China
Contacts
Public ContactZhihong Xie
The Second Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed