Heart failure
Conditions
Interventions
Sequence Group 1:Sacubitril and Valsartan Tablets,Strength:Sacubitril 97 mg/ Valsartan 103 mg,Oral.Will undergo the four-period trial with a single dose treatment of either test or reference product u
Sequence Group 2:Sacubitril and Valsartan Tablets,Strength:Sacubitril 97 mg/ Valsartan 103 mg,Oral.Will undergo the four-period trial with a single dose treatment of either test or reference product u
Sponsors
Hangzhou Combak Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Able to give signed Informed Consent Form before the trial, and fully understand the trial content, process and possible adverse drug reactions (ADRs); 2.Able to complete the trial in compliance with the protocol; 3.Participants (including males) willing to adopt effective contraceptive methods and with no pregnancy plan from 14 days before screening to 3 months after the last scheduled visit; 4.Males and females>=18 and <=55 years old, inclusive; 5.At least 50 kg for males, 45 kg for females, with a Body Mass Index (BMI) = Weight/Height^2 (kg/m^2) between 19.0-26.0 kg/m^2, inclusive. Only those who meet all the criteria listed above can be enrolled.
Exclusion criteria
Exclusion criteria: 1.A history of chronic or serious cardiac, hepatic, renal, digestive tract, nervous system, mental and metabolic disorders, etc.; 2.With = 5 cigarettes per day on average within 3 months before screening, or not able to quit smoking during the trial; 3.Allergic to two or more substances, or specific allergy history (e.g. asthma, allergic rhinitis, urticaria, eczema), or allergic to the drug components and its analogues; 4.A history of alcohol abuse (alcohol consumption of more than 14 units per week : 1 unit of alcohol = 285 mL beer, or 25 mL spirits, or 100 mL wine); 5.Blood donation or massive blood loss (>= 400 mL, except for blood loss during the menstrual period of females) within 3 months before the initial administration; Or any blood donation plan from screening until 1 month after the last administration; 6.A history of dysphagia, or any gastrointestinal disease which may affect the drug absorption; 7.Creatinine clearance <80 mL/min during screening (calculation formula of Creatinine Clearance is detailed in Section 13.3); 8.A history of angioedema; 9.A history of hyperkalemia; 10.Intake of any drug that may have interaction with Sacubitril and Valsartan Tablets within 4 weeks before the initial administration, such as ACEI, aliskiren, ARB, statins, PDE-5 (e.g., sildenafil), potassium-sparing diuretics (e.g., triamterene, amiloride), mineralocorticoid antagonists (e.g., spironolactone, eplerenone), potassium supplements or a salt substitute, NSAIDs (including COX-2 inhibitors), lithium, OATP1B1, OATP1B3, OAT3 inhibitors (e.g., rifampicin, cyclosporine) or MRP2 inhibitors (such as ritonavir), etc.; 11.Any prescription medication within 14 days before the initial administration; 12.Any over-the-counter (OTC) medication or herbal medicine or health supplementary within 7 days before the initial administration; 13.Consumption of any special diets or food items (such as grapefruit), or strenuous exercise engagement, or other factors in the opinion of investigators affecting drug absorption, distribution, metabolism and excretion within 7 days before the initial administration; 14.Participation in other drug clinical trials within 90 days before the initial administration; 15.Any clinically significant abnormality findings, as judged by a investigator, such as physical examination, vital signs, electrocardiogram and laboratory tests; 16.Positive results of viral tests (HbsAg, Anti-HCV,HIV Ag/Ab, Anti-TP); 17.Consumption of chocolate or any food/beverage containing caffeine or rich in xanthine within 48 h before the initial administration; 18.Consumption of any products containing alcohol within 24 h before the initial administration, or a positive result of the alcohol breath test; 19.A positive result of the drug abuse test, or a history of drug abuse in the past 5 years, or intake of any narcotic drugs within 3 months prior to the trial; 20.A clinically significant abnormality finding of the pregnancy test, or in lactation during screening or the test period for female participants; 21.Not tolerable on venipuncture, or a history of fainting on acupuncture and/or blood; 22.Special requirements and unable to follow the unified diet; 23.Unable to participate in this trial for participants’ own reasons; 24.Other conditions in which participants are not suitable for the trial determined by investigators. Those who meet any of the criteria listed above must not be enrolled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary PK endpoints are the maximum plasma concentration (Cmax),areas under the plasma concentration versus time curve calculated to the last measurable observation (AUC0-t) and extrapolated to infinity (AUC0-8) of sacubitril and valsartan.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary pharmacokinetic endpoints are the time to maximum plasma concentration (observed) (T max), the elimination half-life (t1/2) and terminal elimination rate constant (Kel), percentage of AUC0-8due to extrapolation from the last measurable observation to infinity AUC_%Extrap) of sacubitril and valsartan.; | — |
Countries
China
Contacts
Public ContactXiao Guomin
Hangzhou Combak Hospital
Outcome results
None listed