A pivotal, randomized, open-label, two-treatment, two-sequence, four periods, crossover clinical trial to evaluate the bioequivalence of single doses of Test product Sacubitril/Valsartan, film-coated tablets 97 mg/103 mg (Manufacturer: JSC «Farmak», Ukraine) and Reference Entresto®, film-coated tablets 97 mg/103 mg (Novartis Europharm Limited, Ireland) in healthy subjects under fasted conditions
This is a research study looking at a new version of a heart medicine, Sacubitril/Valsartan, made by a company in Ukraine. We want to see if it acts in the body in the same way as the well-known medicine, Entresto, made by Novartis from Ireland. This type of study is called a bioequivalence study and it's important to make sure new medicines work just as effectively as existing ones. Healthy adult volunteers will take both medicines at different times, without food, to compare how their bodies absorb and use them. This helps ensure new medicines are safe and effective alternatives.
At a glance
What is this study about?
This research study is about comparing two versions of a medicine used to treat certain heart conditions. One is a new medicine, Sacubitril/Valsartan, from a company based in Ukraine, and the other is a medicine called Entresto, which is already widely used. We want to find out if the new medicine works in the human body in exactly the same way as Entresto. This is crucial because it helps ensure that patients eventually receive a medicine that is just as safe and effective as the established one.
This kind of study is often called a “bioequivalence study.” Think of it like comparing two different brands of a common household product; you want to make sure they do the same job. In this case, we're making sure the new medicine delivers the same amount of the active ingredients into your bloodstream, and at the same speed, as Entresto. This is done by giving healthy volunteers each medicine at different times and then taking blood samples to measure how the medicine is absorbed and processed by the body.
The study involves healthy people because we want to see how the medicines work without other health conditions affecting the results. The goal is to gather enough information to show that the new medicine is an equal alternative to Entresto, which could eventually offer more choices for patients and the NHS.
Key takeaways
- It compares a new heart medicine with an existing one (Entresto).
- The goal is to see if they are absorbed similarly by the body.
- Only healthy adults aged 18 and over can participate.
- Participants will take both medicines at different times, without food.
- It involves multiple visits and blood samples.
- You won't directly benefit, but you'll help medical research.
Who may be eligible?
This study is looking for healthy volunteers, meaning people who do not have any pre-existing medical conditions. You must be an adult to take part, specifically aged 18 years or older. There is no upper age limit, meaning older adults are also welcome to participate as long as they are healthy.
Both men and women are invited to join this study. We need a mix of participants to ensure the results apply to a wide range of people.
To be considered for this study, you would need to undergo a health check-up to confirm you are in good health and meet all the study's requirements. This check-up is to ensure your safety throughout the trial.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you generally in good health with no major illnesses?
- Are you willing to fast (not eat) before taking medicine?
- Are you comfortable with having blood samples taken regularly?
- Are you available for multiple clinic visits over a period of time?
What does participation involve?
If you decide to take part, you will be asked to visit the study clinic multiple times. You will be given either the test medicine or the reference medicine during each visit. These medicines are tablets taken by mouth. You will take them without food, meaning you will need to fast (not eat) for a certain period before taking the medicine and for some time afterwards. Blood samples will be taken regularly after you take the medicine to measure how it's absorbed by your body.
This study is divided into four main periods. You will take part in two treatment sequences, meaning you'll get both the test medicine and the reference medicine at different times. There will be breaks between each period to allow the medicine to leave your system completely before you take the next dose. The total duration of your participation, including all visits and follow-ups, will be explained in detail by the study team.
Potential risks and benefits
Locations (1)
- —UnverifiedPoland
Common questions
What is Sacubitril/Valsartan?
It's a medicine used to treat certain types of heart failure. This study is testing a new version of it.
Why do you need healthy people for this study?
Using healthy people helps us clearly see how the medicine works in the body without other illnesses affecting the results.
What does 'fasted conditions' mean?
It means you won't eat any food for a certain amount of time before taking the medicine and for a while afterwards.
Will I know which medicine I'm taking?
This study is 'open-label,' which means you and the study team will know which medicine you're receiving at each point.
How long will I be in the study?
The study involves four periods with breaks in between, so the total time will be explained by the research team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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