Randomized, open-label, single dose, three-period, three treatment cross-over bioavailability study comparing test products Rosuvastatin/Ezetimibe, tablets, 20 mg /10 mg or Ezehron Duo, 20 mg + 10 mg, tablet, both administered in combination with Nilemdo 180 mg film-coated tablets to reference products Nustendi 180 mg/10 mg film-coated tablets in combination with Crestor, 20 mg, film-coated tablets in healthy male and female subjects under fasting conditions.
This study is looking at how two different cholesterol-lowering medicines (Rosuvastatin/Ezetimibe and Ezehron Duo) are absorbed and used by the body. Researchers will compare them to common, well-known versions (Nustendi and Crestor). Healthy men and women will take these tablets under medical supervision for a short time. The main goal is to check if the new medicine combinations work similarly to the established ones when it comes to how much medicine gets into your bloodstream. This kind of study helps ensure new medicines are effective and safe before they can be widely used by patients.
At a glance
What is this study about?
This study is designed to understand how different combinations of medicines that help lower cholesterol are taken into your body. Think of it like comparing two different ways to deliver a package: does one way get more of the package (the medicine) to its destination (your bloodstream) faster or more efficiently than the other?
The specific medicines being looked at are ones used to manage cholesterol. Researchers are comparing two new combinations (Rosuvastatin/Ezetimibe and Ezehron Duo) with existing, well-known treatments (Nustendi combined with Crestor). The idea is to make sure these newer combinations work in a similar way when it comes to getting the right amount of medicine into your system. This process is called a 'bioavailability study'.
By doing this study with healthy volunteers, scientists can collect important information about how these medicines behave in the body without the extra complications that might come from studying people who are already unwell. This kind of research is a crucial early step in developing new medicines, helping ensure that any future treatments are safe and work as expected for patients who need them.
Key takeaways
- This study compares how different cholesterol medicines are absorbed.
- It involves healthy adult men and women, aged 18 and over.
- Participants will take different medicine combinations on an empty stomach.
- The study helps ensure new medicines work correctly in the body.
- Strict medical checks will be done throughout your participation.
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 ongoing medical conditions.
Both men and women are welcome to participate. You need to be at least 18 years old to join this study, and there isn't an upper age limit mentioned, as long as you meet the other health criteria.
Because this study is about how medicines are absorbed, it's designed for people who don't already have the conditions these cholesterol medicines treat. This helps the researchers get clear results without other health issues affecting the outcome.
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 serious medical conditions?
- Are you 18 years old or older?
- Are you comfortable taking different medications?
- Are you able to follow specific instructions, such as fasting before medication?
What does participation involve?
If you decide to take part, you would be asked to visit the study clinic on several occasions. During these visits, you would receive the study medication, which consists of various tablets. You would be given different combinations of these medicines at different times, with a break in between each one. You'll take the medicine on an empty stomach (fasting).
Throughout your time in the study, doctors and nurses would carefully monitor your health. This usually involves regular blood tests to see how the medicine is absorbed, and checks of your blood pressure and other vital signs. The total time you spend actively involved in the study, including all visits and follow-up, would be made clear to you before you agree to participate.
Potential risks and benefits
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Common questions
What is the main goal of this study?
The main goal is to compare how different cholesterol-lowering medicines are absorbed by healthy people's bodies.
Who can take part in this study?
Healthy men and women aged 18 or older are invited to participate.
Will I be taking medicines for cholesterol?
Yes, you will take different versions of cholesterol-lowering medicines as part of the study plan.
Do I need to have high cholesterol to join?
No, this study specifically looks for healthy volunteers, not people with high cholesterol, to ensure clear results.
What is a 'fasting condition'?
It means you will need to take the study medicine on an empty stomach, usually after not eating for a certain number of hours.
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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