Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Evaluating Bioequivalence of a Fixed Dose Combination versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Rosuvastatin.

This study is looking at a new combination pill. This pill brings together three different medicines (bempedoic acid, ezetimibe, and rosuvastatin) that are used to help lower cholesterol. Researchers want to see if taking these three medicines together in one pill works in your body in the same way as taking them as three separate pills. This is an important step to make sure the combined pill is just as effective and safe as the individual ones. It helps doctors understand if the new all-in-one pill will deliver the right amount of medicine to your body, making it potentially easier for people to manage their cholesterol levels in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Daiichi Sankyo Europe GmbH

Enrolment target

Start

12 Aug 2025

No medical condition

What is this study about?

Imagine you need to take three different pills every day to help keep your cholesterol in check. Wouldn't it be easier if all three medicines were combined into just one pill? That's exactly what this study is exploring.

Researchers have created a new single pill that contains three medicines: bempedoic acid, ezetimibe, and rosuvastatin. These are all known medicines that doctors prescribe to help lower cholesterol. Before this new combination pill can be used widely, doctors need to be absolutely sure it works just as well as taking the individual pills.

This study is a very early stage of testing, sometimes called 'Phase I'. It's not about treating a specific illness, but rather understanding how the new combined pill behaves in the human body. By comparing it to taking the individual pills, researchers can confirm that your body absorbs the medicines correctly and that the combined pill delivers the same amount of medicine at the right time. This is a crucial step to ensure that if this combination pill becomes available, it will be a safe and effective option for people.

Key takeaways

This study evaluates a new combination pill for cholesterol.
It checks if the combined pill works the same as individual pills.
Healthy adults (18+ years) are needed to participate.
Participation involves clinic visits and blood tests.
Your contribution helps develop new medicine options.
You can stop participating at any time.

Who may be eligible?

This study is looking for healthy adults who are 18 years old or older. Both men and women can take part. Because this is a very early study to check how medicines are handled by the body, you won't have any specific medical conditions or illnesses that could affect the results.

The main goal is to find healthy people who can help researchers understand how these medicines work together. You'll go through screening tests to make sure you're suitable and healthy enough to participate.

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?
Are you generally healthy?
Are you able to attend appointments at a clinic?
Are you comfortable with having blood samples taken?
Do you understand what taking part in a study involves?

Answer every question to see your result.

What does participation involve?

If you join this study, you won't need to take any medicines before starting. You'll likely visit a clinic or research centre several times. During these visits, you'll be given either the new combination pill or the three individual pills. The medical team will take regular blood samples to check how the medicines are being absorbed and processed by your body. You might also have other routine health checks such as blood pressure measurements. The total length of your participation will be explained to you, but these types of studies usually involve a period of close monitoring after you take the medication. The researchers will let you know exactly how many visits you will need to make and how much time it will take up.

Potential risks and benefits

Potential downsides of taking part include the time commitment, multiple blood tests, and possible minor side effects from the medications, such as headaches or stomach upset, although these medicines are generally well-known and their side effects are understood. While there's no direct health benefit to you as a participant, your involvement will be vital in helping develop potentially easier ways for people to manage their cholesterol in the future. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Portugal

Common questions

What is 'bioequivalence'?

It means checking if two different forms of medicine (like a combined pill versus separate pills) deliver the same amount of medicine to your body at the same time.

Will I be given medication?

Yes, you will receive either the new combination pill or the three individual medicines used to lower cholesterol, as part of the study.

Do I need to have high cholesterol to join?

No, this study is actually looking for healthy volunteers, not people with a specific medical condition like high cholesterol. This helps them understand how the medicines work in a standard body.

What does 'Phase I' mean?

Phase I is an early stage of clinical research where medicines are tested in people for the first time, usually in healthy volunteers, to see how they are absorbed and processed by the body and to check for safety.

Will I know which treatment I'm getting?

The study team will explain if you will know which type of pill you are receiving, as sometimes this is kept secret (called 'blinding') to ensure fair results.