Study comparing two formulations 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 study about?

This study involves healthy volunteers and examines two formulations of a medication containing sacubitril and valsartan. The medication being tested is Entresto, which comes in tablet form and is taken by mouth. One formulation is a test version and the other is a commercial reference version that is already available on the market. Both formulations 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 the same way. During the study, participants will receive a single dose of the medication under fasting conditions, which means they will not have eaten before taking the tablet. The study uses a crossover design, meaning that each participant will receive both formulations at different times with a period of rest in between to allow the medication to clear from the body. Blood samples will be collected at specific times to measure the levels of the active substances in the bloodstream.

The study will measure several factors to determine if the two formulations are equivalent, including the total amount of each active substance that enters the bloodstream over time and the highest level reached in the blood. Additional measurements will look at how long it takes for the medication to reach its highest level and what percentage of the substance remains in the body after a certain period. The entire treatment period for each participant is expected to last up to two weeks.

1 Initial screening and admission

Your medical history will be reviewed and a physical examination will be performed to ensure there are no significant health issues.

Blood samples will be collected for laboratory tests including haematology (blood cell counts), coagulation (blood clotting ability), biochemistry (chemical substances in blood), and serology (tests for hepatitis B surface antigen, hepatitis C antibodies, and HIV antibodies).

A urine sample will be collected for urinalysis (urine testing).

Your vital signs will be measured, including blood pressure, heart rate, and body temperature.

An electrocardiogram (a test that records the electrical activity of your heart) will be performed.

If all results are within acceptable ranges and you meet the study requirements, you will be admitted to the trial.

2 First treatment period

You will be required to fast before receiving the medication.

You will receive a single oral dose of either the test formulation or the reference formulation of sacubitril/valsartan 49 mg/51 mg film-coated tablets.

The medication will be taken by mouth with water.

Blood samples will be collected at specific time points after taking the medication to measure the levels of sacubitril and valsartan in your bloodstream.

Your vital signs and overall condition will be monitored during this period.

3 Washout period

A period of time will pass between the first and second treatment periods to allow the medication to be completely eliminated from your body.

The duration of this washout period will be determined by the study protocol.

4 Second treatment period

You will again be required to fast before receiving the medication.

You will receive a single oral dose of the other formulation of sacubitril/valsartan 49 mg/51 mg film-coated tablets that you did not receive in the first period.

The medication will be taken by mouth with water.

Blood samples will be collected at specific time points after taking the medication to measure the levels of sacubitril and valsartan in your bloodstream.

Your vital signs and overall condition will be monitored during this period.

5 Additional treatment periods if applicable

This study uses a replicated crossover design, which means you may participate in additional treatment periods.

Each additional period will follow the same procedure as the previous treatment periods, with fasting, medication administration, blood sample collection, and monitoring.

A washout period will occur between each treatment period.

6 Final assessment and completion

After completing all treatment periods, a final medical assessment will be performed.

Your vital signs will be measured and your overall health status will be evaluated.

Once all required assessments are completed and you are determined to be in good health, your participation in the trial will be concluded.

Who Can Join the Study?

You must be willing to participate in the study after receiving full information about its design, objectives, and possible risks, and you must sign a written consent form showing that you agree to take part and understand that you can withdraw at any time.
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.
Your medical history, which is a record of your past health problems and treatments, and your physical examination, which is when a doctor checks your body, must not show any significant abnormalities.
Your blood tests must be normal, including tests for haematology which checks your blood cells, coagulation which measures how well your blood clots, biochemistry which checks chemicals in your blood, serology which tests for infections like Hepatitis B, Hepatitis C, and HIV, and urinalysis which examines your urine.
Your vital signs, which include measurements like blood pressure, heart rate, breathing rate, and body temperature, and your electrocardiogram, which is a test that records the electrical activity of your heart, must not show any significant abnormalities.

Who Cannot Join the Study?

The study does not provide specific exclusion criteria, which are conditions or factors that would prevent someone from joining the trial
Since this study involves healthy volunteers, meaning people without any diseases, typical reasons for not being able to participate would likely include having any current illness or medical condition
Being pregnant or breastfeeding may prevent participation, as this is common in studies testing medications
Taking certain medications that could interfere with the study drug may not be allowed
Having allergies to the study medication or its ingredients would prevent participation
Having abnormal results in laboratory tests, which are blood or urine tests that check how your body is functioning, may be a reason for exclusion
Recent participation in another clinical trial may not be permitted
Having a history of drug or alcohol abuse may prevent you from joining

Where you can join this trial?

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Site Name	City	Country	Status
Hslxuqyh Ucbjphhyiiiaa Da Lr Pwrtnkpl	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	22.05.2023

Trial locations

Investigated drugs:

Sacubitril/valsartan is a combination medication used to treat heart failure. It works by helping blood vessels relax and widen, making it easier for the heart to pump blood throughout the body. This medicine combines two active ingredients that work together to reduce the strain on the heart and improve its function.

Healthy volunteers – This study involves healthy volunteers, which means participants who do not have any diseases or medical conditions being studied. Healthy volunteers are individuals who meet specific health criteria and do not show signs of illness. They participate in research to help evaluate medications or treatments in people without the target disease. These participants serve as a comparison group or help researchers understand how a drug works in a normal, healthy body. The study focuses on testing the bioavailability of medication formulations in individuals without medical conditions. Healthy volunteers are carefully screened to ensure they meet the health requirements for safe participation in the research.

Trial ID:

2023-505237-27-00

Protocol code:

N-SACVAL-23-278

Trial Phase:

Human Pharmacology (Phase I) – Bioequivalence Study

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Study comparing two formulations of sacubitril and valsartan tablets in healthy volunteers to check if they work the same way in the body

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?