Chronic heart failure, high blood pressure
Conditions
Interventions
Fasting group (RTRT):reference preparation- test preparation- reference preparation- test preparation
Sponsors
Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Fully understand the content of the informed consent and sign it voluntarily to participate in the study; 2) Able to communicate well with researchers and complete the research according to the requirements of the research protocol. 3) Age: healthy adult male and non-pregnant non-lactating adult female subjects aged 18 years and above; 4) Weight: male need =50.0kg, female need =45.0kg, [BMI= weight (kg)/height^2 (m^2)] in 19.0~26.0kg/m^2 (including the critical value)
Exclusion criteria
Exclusion criteria: 1) Patients who have undergone surgery within 3 months prior to screening or plan to undergo surgery during the study period, and surgery will affect drug absorption, distribution, metabolism, and excretion; 2) People who are allergic (allergic to two or more drugs and food), or are known to be allergic to sacubactril, or valsartan, or any excipients of this product; 3) Blood donation or significant blood loss (>450mL) within 3 months prior to screening, or plans to donate blood during the study period (from the screening date to the last cycle of discharge), or plans to donate blood within 1 month after the end of the study; 4) Those who received vaccination within 1 month prior to screening or planned to receive vaccination during the study period; 5) Those who smoked more than 5 cigarettes per day on average in the 3 months before screening, or did not agree or could not stop consuming any tobacco products during the study period (from the screening date to the last cycle of discharge); 6) Regular drinkers in the 3 months prior to screening, that is, those who drank more than 14 units of alcohol per week (1 unit ˜360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine), or who could not guarantee abstaining from drinking during the trial; 7) Those who have used drugs in the previous 12 months or have a history of drug abuse; 8) Clinically significant diseases have occurred or are occurring in the 12 months prior to screening, including but not limited to neurological/psychiatric, respiratory, cardiovascular and cerebrovascular systems, digestive system (history of dysphagia or any gastrointestinal disease affecting drug absorption), blood and lymphatic system, liver and kidney function, endocrine system, and immune system diseases; 9) History of angioedema, or biliary cirrhosis, or cholestasis, or hyperkalemia, or hypotension, or family history, or infectious disease; 10) Used any prescription drugs, non-prescription drugs, Chinese herbs, vitamins or health products within 2 weeks before screening; 11) Use of any drug that inhibits/induces liver metabolism of drugs (e.g., inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole) within 30 days prior to screening; Inhibitors --SSRI antidepressants, cimetidine, Diltiazem, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines.) Or any drug that alters the gastrointestinal environment, such as the proton pump inhibitors tatoprazole, omeprazole, Lansoprazole, esoprazole, etc.; H2 antagonists ranitidine, cimetidine, famotidine, etc. Antacid sodium bicarbonate, magnesium oxide, aluminum hydroxide, magnesium trisilicate, etc.; Gastric mucosal protective agents such as sulfoaluminum). Or drugs that can interact with sacubatrol valsartan tablets (e.g., angiotensin-converting enzyme inhibitors (e.g., captopril, enalapril), aligilen, angiotensin II receptor antagonists, statins, sildenafil, potassium-keeping diuretics (e.g., amiloride), salt-corticosteroid receptor antagonists (e.g., spironolactone, eplenone), potassium supplements Or potassium-containing salt substitutes, non-steroidal anti-inflammatory drugs, lithium agents, OATP1B1, OATP1B3, OAT3 inhibitors (such as rifampicin, cyclosporin) or MRP2 inhibitors (such as ritonavir); 12) Excessive consumption of tea, coffee and/or caffeinated beverages (more than 8 cups on average, 1 cup ˜250mL, including chocolate, coffee, cola and any food rich in xanthines) per day in the 3 months prio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics;Physical examination;adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| 12 lead electrocardiogram; laboratory examination; | — |
Countries
CHINA
Contacts
Public ContactCHEN GUILING
Shulan (Hangzhou) Hospital
Outcome results
None listed