Randomized, open-label, laboratory-blinded, balanced, single dose, 3-treatment, 6-sequence, 3-period crossover comparative bioavailability study comparing Finerenone, 20 mg, film-coated tablets (Prototype 1, Prototype 2) and Kerendia, 20 mg, film-coated tablets under fasting conditions in healthy participants.
This research is looking at different versions of a medicine called Finerenone. We're comparing two new tablet types (we're calling them Prototype 1 and Prototype 2) with a tablet that's already approved, called Kerendia. The main goal is to understand how well your body absorbs each version of the medicine when you haven't eaten anything. This is important to make sure new medicines work as expected. Healthy adults aged 18 and over are needed to take part in this study. It's an early-stage study, meaning we're testing how the medicine acts in the body in a controlled way.
At a glance
What is this study about?
This study is about a medicine called Finerenone. You might know it by its brand name, Kerendia. Researchers have developed two new versions of this medicine, which they are calling Prototype 1 and Prototype 2. The main purpose of this study is to compare how your body handles these new versions against the existing Kerendia tablet.
Specifically, the researchers want to see how much of the medicine gets into your bloodstream from each type of tablet. This is called 'bioavailability'. We are interested in this because it helps us understand if the new versions of the medicine work in the same way as the original, approved one. This is a very important step when new medicines are being developed or when existing medicines are being made in a different way or by a new company.
The study is being done under 'fasting conditions,' which means you won't have eaten anything before taking the medicine. This helps ensure that food doesn't affect how your body absorbs the medicine, giving us a clearer picture of how each tablet performs on its own. This is an early-stage study, often called 'Phase I', where we learn how the medicine acts in healthy people.
Key takeaways
- Compares two new versions of Finerenone with existing Kerendia tablets.
- Aims to understand how much medicine your body absorbs (bioavailability).
- Only for healthy adults, aged 18 and over.
- Involves taking medicine on an empty stomach and having regular blood tests.
- Helps develop new medicines safely and effectively.
Who may be eligible?
This study is looking for healthy adults. You need to be at least 18 years old to take part, and there's no upper age limit mentioned. Both men and women can join the study.
To be considered healthy, you would generally not have any major ongoing health conditions or be taking long-term medications that could interfere with the study. The medical team will conduct checks to make sure you are suitable and that participating would be safe for you.
Even if you meet the age and sex requirements, there might be other specific reasons why you couldn't join. For example, if you have certain medical conditions, allergies to the study medicine, or are pregnant or breastfeeding, you would likely not be able to take part. These details would be fully explained 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 18 years old or older?
- Do you consider yourself generally healthy?
- Are you able to fast before taking medication?
- Are you comfortable with having blood samples taken regularly?
- Are you not currently pregnant or breastfeeding (if applicable)?
What does participation involve?
If you join this study, your participation will involve several visits to the study clinic. Since this is a 'crossover' study, you will receive each of the three different versions of the medicine (Prototype 1, Prototype 2, and Kerendia) at different times. After taking each medicine, you will have blood samples taken regularly to measure how much of the medicine is in your body over time. These blood tests usually happen over several hours or even a day after you take the medicine.
You will need to fast, meaning not eat, before taking the medicine on each occasion. There will be rest periods between receiving each different medicine to allow the previous dose to leave your system completely before starting the next. You will undergo medical checks, including physical exams and other tests, at the start and throughout the study to ensure your safety and monitor your health. The total duration of your involvement will be explained by the study team, but typically, these types of studies involve a screening visit, three main dosing periods, and a follow-up visit.
Potential risks and benefits
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Common questions
What is Finerenone?
Finerenone is a medicine used for certain heart and kidney conditions. This study is testing new versions of this medicine.
Why do I need to fast?
Fasting means not eating before taking the medicine. This is done so researchers can clearly see how your body absorbs the medicine without food interfering.
Is this a new medicine?
Kerendia (Finerenone) is an existing medicine. This study is comparing two new versions of the tablet with the existing one.
How long will I be in the study?
The exact duration will be explained by the study team, but these types of studies usually involve several visits over a few weeks or months.
Will I get paid for taking part?
Most studies for healthy volunteers offer some payment for your time and travel, but this would be confirmed by the study site.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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