Hospital Universitario De La Princesa
Madrid, Spain
Not recruiting
Comparing Two Forms of Sacubitril and Valsartan Tablets in Healthy Volunteers to Check if They Work the Same Way in the Body
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This study involves healthy volunteers and examines two formulations of a medication that combines sacubitril and valsartan. The medications being tested are film-coated tablets containing 97 mg of sacubitril and 103 mg of valsartan. One formulation is a test product called Sacubitrilo/valsartán Normon, and the other is a reference product called Entresto. Both medications are taken by mouth and contain the same active substances in the same amounts.
The purpose of the study is to compare how the body absorbs and processes the test formulation compared to the reference formulation and to show that they work in a similar way in the body. This type of study is called a bioequivalence study, which means researchers want to demonstrate that the two formulations behave similarly when taken by healthy volunteers.
The study follows a crossover design, which means that participants will receive both formulations at different times with a break between doses. Volunteers will take a single dose of each medication under fasting conditions, meaning they will not have eaten before taking the tablets. Blood samples will be collected to measure the levels of sacubitril and valsartan in the body over time. This allows researchers to compare how quickly and how much of each active substance enters the bloodstream with each formulation.
The research process
The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
7 criteria
- You must be able to understand the study design, objectives, and possible risks, and you must provide your written consent to participate, which means you agree in writing to take part after being fully informed
- You must be between 18 and 55 years old
- You must not have any significant physical or mental health conditions that could affect the study
- You must have normal results from a physical examination, which is when a doctor checks your body for any health problems, and your medical records must not show any important health issues
- You must have normal results from blood tests, including tests for haematology (which checks your blood cells), coagulation (which checks how your blood clots), biochemistry (which checks chemicals in your blood), serology (which checks for infections like hepatitis B, hepatitis C, and HIV), and urinalysis (which is a urine test)
- You must have normal vital signs, which include measurements like blood pressure, heart rate, and body temperature, and a normal electrocardiogram, which is a test that records the electrical activity of your heart
- Both men and women can participate in this study
Who cannot join the trial?
10 criteria
- The study does not include vulnerable populations, which means people who may need special protection or care, such as children, pregnant women, or people who cannot make decisions for themselves
- You cannot participate if you are not a healthy volunteer, meaning you must be in good health without any significant medical conditions or diseases
- You cannot participate if you do not meet the required age range set for this study
- You cannot participate if you have any serious medical conditions that could affect the study results or put your health at risk
- You cannot participate if you are taking medications that might interact with the study drug sacubitril/valsartan, which is a medicine normally used to treat heart problems
- You cannot participate if you have allergies or bad reactions to sacubitril, valsartan, or similar medicines
- You cannot participate if you are pregnant, breastfeeding, or planning to become pregnant during the study
- You cannot participate if you have problems with your liver or kidneys that affect how your body processes medicines
- You cannot participate if you have recently taken part in another clinical trial
- You cannot participate if you use tobacco, alcohol, or drugs in ways that could affect the study results
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Investigated drugs
Sacubitril/valsartan is a combination medication that contains two active substances working together. This medicine is used to help the heart pump blood more effectively. In this trial, researchers are comparing different versions of this medication to make sure they work the same way in the body.
What is already known about the treatment
Sacubitril/Valsartan – This medication is a combination tablet taken by mouth that contains two active substances working together to treat heart failure. Sacubitril works by blocking an enzyme that breaks down natural substances in the body which help blood vessels relax and widen, while valsartan blocks receptors that cause blood vessels to narrow, and together they help reduce the strain on the heart and improve blood flow. This medicine belongs to a class of drugs called angiotensin receptor neprilysin inhibitors and is widely approved and used in clinical practice for patients with chronic heart failure. The medication is currently being studied in bioequivalence trials to compare different formulations and ensure they work the same way in the body.
Investigated diseases
Healthy volunteers – This study involves healthy volunteers, which means the participants do not have any disease or medical condition being studied. Healthy volunteers are individuals who participate in clinical research to help test new medications or treatments without having the illness the drug is intended to treat. They serve as a comparison group to understand how a medication works in people without health problems. In this case, the study examines how the body processes a combination medication containing sacubitril and valsartan. The volunteers help researchers understand the basic effects of the drug in healthy bodies. No disease progression is involved since the participants are healthy individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-503083-32-00Protocol codeN-SACVAL-22-275Estimated enrolment36 patientsSponsorLaboratorios Normon S.A.
sourced from the EU Clinical Trials Register and site verification
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