Randomised bioequivalence clinical trial of sacubitril/valsartan 49 mg/51 mg film-coated tablets, after a single oral dose administration to healthy volunteers under fasting conditions in crossover replicated design.
This clinical trial is designed to see if a new, generic version of a heart medication, similar to Entresto (Sacubitril/Valsartan), works in exactly the same way as the original. We call this a 'bioequivalence' study. Healthy volunteers will be given a single dose of the original medication and then, after a short break, a single dose of the new version. This helps us compare how much of the active ingredients (sacubitril and valsartan) each tablet delivers into the body and how quickly it gets there. The main goal is to ensure the new medication is just as effective and safe as the original, meaning your body uses it in the same way.
At a glance
What is this study about?
Imagine you have a new brand of your favourite snack, and you want to be sure it tastes exactly the same as the original. This study is a bit like that, but for an important heart medication. We're looking at a medicine that's usually used for heart conditions, and there's a new version of it, called Sacubitril/Valsartan Normon. Before this new version can be used more widely, we need to be absolutely sure it acts in the body in the same way as the original medication, Entresto.
This kind of study is called a 'bioequivalence' study. It means we're comparing how two different versions of the same medicine are absorbed and used by your body. We need to measure how much of the active ingredients, called sacubitril and valsartan, get into your bloodstream and how long they stay there after you take each tablet. If the amounts are very similar, then the new version is considered 'bioequivalent' – meaning it will work just as well as the original.
This is a really important step in developing new medicines. It helps ensure that when you're prescribed a medication, whether it's the original or a new generic version, you can be confident that you're getting the same treatment effect. This study focuses on healthy volunteers, which helps us see how the medication behaves in a straightforward way, without other health conditions making it complicated.
Key takeaways
- Tests a new version of a heart medication against the original.
- Aims to ensure the new version works exactly the same way.
- Looks for healthy adult volunteers, aged 18 and over.
- Involves two short stays at a clinic and blood samples.
- Helps confirm new medicines are safe and effective.
Who may be eligible?
This study is looking for healthy adult volunteers. 'Healthy' means you don't have any major ongoing health conditions that would affect how the medication works or how your body handles it. You would have a health check by the study doctors to confirm you are healthy enough to take part.
Participants must be at least 18 years old. There is no upper age limit, as long as you are considered healthy by the study team.
Both men and women are welcome to participate in this study.
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?
- Do you consider yourself generally healthy?
- Do you currently take any regular medications (excluding contraceptives)?
- Are you able to attend clinic visits for a full day or overnight?
- Are you comfortable having regular blood samples taken?
What does participation involve?
If you decide to take part, you'll first have a health check to make sure you're suitable. Once confirmed, you'll attend the study clinic for two separate visits. Each visit will involve staying overnight or for a full day. On these visits, you'll be given a single dose of one of the medications (either the original or the new version), and then on the other visit, you'll receive the other medication. You won't know which one you're getting first, and neither will the study team, to keep things fair.
After taking each dose, blood samples will be taken regularly over several hours. These blood tests help us measure how much of the medication is in your body and how long it stays there. You'll have a wash-out period between the two visits, meaning a break where you don't take any study medication, to make sure the first dose has completely left your body before you take the second. The total time you'd be involved in the study, including all visits and the break in between, would be a few weeks.
Potential risks and benefits
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Common questions
What is Entresto for?
Entresto is a medication often prescribed for people with certain heart conditions, particularly heart failure.
What does 'healthy volunteers' mean?
It means we are looking for people who do not have any significant ongoing illnesses or take long-term medications that could affect the study results.
Will I get paid for taking part?
Most bioequivalence studies offer some payment to volunteers for their time and inconvenience. This would be explained if you inquire further.
What is a 'single oral dose'?
It means you will take just one tablet of the study medication on each study day, swallowed with water.
Will I know which medication I receive?
You won't know whether you're getting the original or the new version on each study day, and neither will the study staff. This is called 'blinding' and helps keep the results unbiased.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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