Randomised bioequivalence clinical trial of sacubitril/valsartan 97 mg/103 mg film-coated tablets, after a single oral dose administration to healthy volunteers under fasting conditions in crossover replicated design.
This research study is focused on a medicine used to treat heart failure, called sacubitril/valsartan. We are testing two different versions of this medicine: the original Entresto and a new generic version called Sacubitrilo/valsartán Normon. The main goal is to see if these two medicines are the same in how they act in the body. This is called 'bioequivalence.' We'll be giving a single dose of each medicine to healthy volunteers on different occasions, ensuring they haven't eaten beforehand. Researchers will then measure how much of the medicine gets into the bloodstream and how quickly. This helps ensure that the new generic medicine works just like the original one.
At a glance
What is this study about?
This study is looking at a medicine called sacubitril/valsartan. This medicine is commonly used to help people with heart failure. When a company creates a new medicine, it's called a 'pioneer' or 'brand-name' drug (in this case, Entresto). After a certain time, other companies can create their own versions, known as 'generic' medicines. These generics are usually much cheaper, making essential medicines more accessible.
The main purpose of this study is to check if a new generic version of sacubitril/valsartan, called Sacubitrilo/valsartán Normon, works exactly the same way as the original Entresto. Scientists call this a 'bioequivalence' study. It means they want to make sure that the generic version releases the same amount of medicine into your bloodstream, and at the same speed, as the brand-name version. If they are bioequivalent, it means patients can switch between them without any difference in how well the medicine works.
To do this, healthy volunteers will take a single dose of each medicine on separate occasions. Researchers will then take blood samples at different times to measure the levels of sacubitril and valsartan in the body. This helps confirm that patients would get the same benefits from the new generic medicine as they would from the original.
Key takeaways
- This study compares a new generic heart failure medicine with the original.
- It aims to ensure both versions work identically in the body.
- Healthy volunteers are needed to take a single dose of each medicine.
- Blood samples will be taken to measure drug levels.
- Participation helps make medicines more affordable and accessible.
- You must be at least 18 years old and in good overall health.
Who may be eligible?
This study is looking for healthy adults to take part. This means you should generally be in good health and not have any serious medical conditions.
You must be at least 18 years old to participate. There's no upper age limit, but you should be well enough to safely take part in the study and follow all the instructions.
Both men and women are welcome to join this study. The most important thing is that you are healthy, as confirmed by medical checks by the study team.
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 generally healthy with no major medical problems?
- Are you 18 years old or older?
- Are you comfortable having regular blood samples taken?
- Can you follow specific instructions, like fasting before medication?
- Are you available for clinic visits over a period of time?
What does participation involve?
If you decide to take part, you would receive a single dose of the study medicine on two separate occasions. These will be different types of sacubitril/valsartan. You'll switch between them – one time you'll get the original, and the other time you'll get the generic. This is called a 'crossover' design. Before each dose, you'll need to fast, meaning you won't be able to eat anything for a certain amount of time.
After taking the medicine, you will have several blood samples taken over a few hours. This helps the researchers understand how the medicine is absorbed and cleared from your body. You might also have other checks, like blood pressure or heart rate measurements, to ensure you remain well. The study involves a few visits to the clinic for drug administration and follow-up, with a period of time between the different drug doses to allow the first medicine to leave your system completely. The total duration of your participation will depend on the time between these dosing occasions and follow-up visits.
Potential risks and benefits
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Common questions
What is 'bioequivalence'?
It means we're checking if the new generic medicine works in the body in the exact same way as the original, meaning it delivers the same amount of medicine at the same speed.
Why use healthy volunteers?
By using healthy volunteers, researchers can focus solely on how the medicine is absorbed and processed by the body, without other health conditions making the results unclear.
What is sacubitril/valsartan used for?
It's a medicine commonly prescribed to help manage heart failure.
Will I know if I'm getting the original or generic medicine?
You will receive both types at different times, but you might not know which one you're getting on a particular day. This helps ensure fair and unbiased results.
How long will I need to fast?
The study team will tell you the exact fasting requirements, but it usually means you can't eat anything for a certain number of hours before taking the medicine.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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