Heart failure
Conditions
Interventions
Fasting dosing group:Subjects were randomly assigned to one of two dosing groups (T-R-T-R group, R-T-R-T group) in a 1:1 ratio. The first cycle: After fasting and not fasting for more than 10 hours, t
After fasting and not watering for more than 10 hours, the subjects in the R-T-R-T group took 11 tablets of the reference preparation (R, Noxinto 200mg, 240mL warm water, 1 h before and 2 h after taki
The washing period is 7 days
The first, second, third and fourth cycles are administered alternately, and the drug method is the same as that of the first cycle, and the investigator assigns the study drug to each stage of the st
Postprandial dosing group:Subjects were randomly assigned to one of two dosing groups (T-R-T-R group, R-T-R-T group) in a 1:1 ratio. The first cycle: After fasting and not fasting for more than 10 hou
Subjects in the R-T-R-T group fasted for more
Sponsors
Affiliated Hospital of Hebei University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Sex: healthy adult male and female subjects; 2.Age: over 18 years old (including 18 years old); 3.Weight: male subjects should not be lower than 50.0kg, female subjects should not be lower than 45.0kg, and body mass index BMI [weight (kg) / height^ 2 (m^2)] within the 19.0kg/m2~26.0kg/m^2 range (including critical value); 4.Have the ability to communicate with medical staff and comply with the relevant hospital management regulations; 5.Subjects must give informed consent to this study before screening and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1) Those who have a history of any chronic or serious diseases such as hematologic, circulatory, digestive, urinary, respiratory, nervous, nervous system, immune system, endocrine system, mental abnormalities or metabolic abnormalities, or any other diseases or physiological conditions that can interfere with the test results; 2) Those who have previous or current chronic or active digestive tract diseases/symptoms or have a history of gastrointestinal surgery in the past or plan to undergo gastrointestinal surgery during the study, affecting digestion and absorption; 3) Those with hereditary or idiopathic angioedema disease or a history of angioedema; 4) Patients with a history of orthostatic hypotension; 5) Patients with biliary cirrhosis and cholestasis; 6) Have a history of fainting needle or blood sickness; Those who cannot tolerate venipuncture or have difficulty in blood collection; 7) Those who have undergone surgery within 3 months before screening or plan to undergo surgery during the trial; 8) Those who donate or lose blood (200 mL or more), receive blood transfusion or use blood products, or plan to donate blood or platelets during the trial within 3 months before screening; 9) Those who are allergic to sacubitril or valsartan, or those who are allergic to other ingredients of medicines, or lactose intolerant (those who have had diarrhea from drinking milk), or those who are allergic; 10) Those who have participated in any clinical trial within 3 months before screening, or those who fail to pass the net screening; 11) Those who have a history of drug abuse in the past five years, or have used drugs within 3 months before screening, or who are positive in urine screening for drug abuse (including morphine, methamphetamine, ketamine, dimethylenedioxyamphetamine, tetrahydrocannabinolic acid); 12) Those who have received vaccination within 4 weeks before screening, or those who plan to be vaccinated during the trial; 13) Those who have used any drugs (including chemical drugs, health products or Chinese herbal medicines) within 4 weeks before screening, including but not limited to any drugs that change the activity of liver enzymes (common liver enzyme inducers: phenobarbital, phenytoin, carbamazepine, aminolutide, griseofulvin, methamethyl, phenytoin, glunomide, rifampicin, dexamethasone; Common liver enzyme inhibitors: probenecid, chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamides) or drugs that interact with sacubitril-valsartan (such as: ACE inhibitors, ARBs, aliskiren, statins, sildenafil, potassium-sparing diuretics, NSAIDs, lithium preparations, transporter inhibitors, etc.); 14) Those who have consumed too much tea, coffee or caffeinated beverages for a long time (more than 8 cups a day, 1 cup = 250 mL) in the past; Those who have ingested any beverage or food rich in grapefruit, grapefruit juice or other beverages or foods that affect the absorption, distribution, metabolism, excretion, etc. of drugs within 7 days before administration; or those who do not agree to stop consuming the above drinks and foods during the trial; 15) Previous alcohol abuse, that is, drinking more than 28 standard units per week (1 standard unit contains 14g (17.7mL) of alcohol, such as 1 unit = 357 mL of beer with 5% alcohol or 43 mL of liquor with 40% alcohol or 147 mL of wine with 12% alcohol), or regular drinking (more than 14 standard units of alcohol per week) within 6 months before scree
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic metrics (time to peak/peak concentration/elimination half-life/elimination rate constant/area under the plasma drug concentration-time curve (AUC) from administration (0h) to the last measurable plasma concentration time point/area under the plasma drug concentration-time curve from dosing (0h) to extrapolated to infinity (AUC.) );90% confidence interval for the test preparation/reference preparation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation indicators (vital signs, laboratory indicators, ECG, etc.);Incidence of adverse events/adverse reactions; | — |
Countries
China
Contacts
Public ContactZhao Yongchen
Affiliated Hospital of Hebei University
Outcome results
None listed