(22292) Randomized, non-blinded, two-way crossover study to assess bioequivalence between finerenone 2 x 20 mg tablets and 1 x 40 mg tablet in healthy male adult participants
This research is looking into a medication called finerenone, which is used for heart conditions. Specifically, it's comparing if taking two 20mg finerenone tablets has the same effect in the body as taking one 40mg finerenone tablet. This type of study, called a bioequivalence study, helps ensure that different ways of giving a drug work similarly. They will be looking at how quickly the drug gets into the bloodstream and how much of it stays there over time in healthy adult men. The main goal is to see if both approaches deliver the same amount of medication to your system.
At a glance
What is this study about?
This study is about a medicine called finerenone. It's one of the first steps in understanding how this medicine works, specifically when given in different forms. Think of it like this: sometimes a medicine comes in different strengths, or you might need to take one tablet versus splitting the dose into two. The researchers want to make sure that taking two smaller 20mg tablets of finerenone has exactly the same effect inside your body as taking one larger 40mg tablet.
The main idea is to see if your body absorbs the finerenone in the same way, regardless of whether it's two smaller pills or one larger one. They'll measure how much of the medicine gets into your blood and how long it stays there. This is important because it tells us if the different ways of taking the medicine deliver the same amount of the active drug to where it needs to go in your body.
This kind of research is really important for medicines. It helps pharmaceutical companies make sure that if they change the tablet size or dose, it doesn't change how well the medicine works or if it causes different side effects. It’s part of a careful process to make sure medicines are safe and effective for patients with heart conditions.
Key takeaways
- This study compares two ways of taking a heart medicine, finerenone.
- It checks if taking two 20mg tablets works the same as one 40mg tablet.
- Only healthy adult men can join this specific part of the research.
- The main goal is to understand how the medicine is absorbed by the body.
- Participants will take both tablet forms at different times.
Who may be eligible?
To take part in this study, you need to be an adult male, at least 18 years old. The study is specifically looking for healthy male volunteers. This means that, ideally, you shouldn't have any major ongoing health problems or be taking a lot of regular medication that could affect how the study drug works.
The study is not for people who have certain heart conditions, even though the medicine finerenone is used for such conditions in general. For this particular study, they need healthy individuals to accurately measure how the drug is absorbed without other health issues complicating the results. The specific heart condition mentioned, 'heart failure with left ventricular ejection fraction ≥40%', refers to a type of heart problem that they are NOT enrolling for this specific study, because they need healthy volunteers to test the drug's basic absorption.
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.
- Am I at least 18 years old?
- Am I male?
- Do I generally consider myself to be in good health?
- Do I currently have any major ongoing medical conditions?
- Am I currently taking any regular prescription medications?
What does participation involve?
If you decide to take part, you'll be involved in a 'crossover' study. This means you'll try both ways of taking the finerenone (two 20mg tablets at one time, and one 40mg tablet at another time). There will be a 'washout' period in between, where you won't take any study medicine, to make sure the first dose is completely out of your system before you start the second.
During your time in the study, you would likely have several visits to a clinic. At these visits, you’d be given the study medicine, and then blood samples would be taken regularly over a set period to measure how much finerenone is in your blood. You might also have general health checks, like measuring your blood pressure and heart rate. The total duration of your involvement, including all visits and the washout period, would be explained to you in detail by the study team.
Potential risks and benefits
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Common questions
What is finerenone?
Finerenone is a medication used to treat certain heart conditions, specifically a type of heart failure.
Why are two different tablet doses being compared?
Researchers want to check if taking two smaller tablets delivers the same amount of medicine to your body as one larger tablet, ensuring consistency for patients.
Who can take part in this study?
This particular study is looking for healthy adult men aged 18 and over.
What does being 'healthy' mean for this study?
It generally means you don't have any major ongoing medical conditions or take regular medications that could interfere with the study's results.
Will I get paid for taking part?
Some studies offer compensation for your time and travel, but you would need to ask the study team for specific details about this study.
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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