Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

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

This research is looking at a new way to help people manage their cholesterol. Currently, some people might need to take three different medications: Bempedoic Acid, Ezetimibe, and Atorvastatin. This study wants to find out if putting all three into one single pill works just as well inside the body as taking them separately. It's a 'bioequivalence' study, which means researchers are checking if the body absorbs and uses the combined pill in the same way as the individual ones. This is a very early phase of testing new medicines, done in healthy volunteers, to ensure future combined treatments are effective and safe before they can be used more widely. It’s a key step in developing simpler treatment options.

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 have to take a few different medicines every day. It can sometimes be tricky to remember them all. This study is exploring a new way to help people who need specific medications to manage their cholesterol. Currently, some individuals might be taking three separate tablets: Bempedoic Acid, Ezetimibe, and Atorvastatin. Each of these medicines works in a different way to help lower cholesterol levels.

The main goal of this research is to see if a new tablet that combines all three of these medications into one single pill works exactly the same way in your body as taking the three separate pills. This is called a 'bioequivalence' study. It means the researchers are checking if the new combined pill delivers the medicine to your body at the same speed and in the same amounts as the individual pills do. This is a really important step because it helps to ensure that if a combined pill is eventually made available, it will be just as effective as taking the separate medicines.

This type of study is an early stage of testing new medicines, often called 'Phase I'. It's usually done in healthy volunteers to gather basic but crucial information about how the new combined medicine behaves in the human body. Finding a single pill that works as well as multiple pills could make it much easier for people to take their medication as prescribed, potentially leading to better health outcomes in the long run. It's all about making treatments simpler and more convenient.

Key takeaways

This study compares a new combined cholesterol pill to three separate ones.
It aims to ensure the combined pill works just as effectively in the body.
Participation is for healthy adults, aged 18 and over.
Involves clinic visits, blood tests, and careful medical observation.
Helps advance simpler ways to manage cholesterol for future patients.
You can stop participating at any time.

Who may be eligible?

This study is looking for healthy adult volunteers. You need to be at least 18 years old to take part. There is no upper age limit, meaning older adults are also welcome to participate if they meet the other health requirements.

Because this is a study to see how a new combined medicine works in the body compared to separate ones, you must be in generally good health. This means you shouldn't have any specific medical conditions that might interfere with how your body handles the medication or the study procedures. The aim is to study the medicines in a typical healthy body.

Both men and women are welcome to participate in this research. The medical team will conduct various health checks to make sure you are suitable and that taking part would be safe for you. This often includes blood tests, physical examinations, and reviewing your medical history to ensure you are healthy enough for the 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?
Are you generally in good health?
Do you have no significant ongoing medical conditions?
Are you willing to attend multiple clinic visits?
Are you comfortable with having blood samples taken regularly?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve several visits to a clinic over a period of time. During these visits, you will be given either the new combined pill or the three separate pills. Researchers will then closely monitor how your body processes these medicines. This usually involves taking blood samples at specific times to measure the medicine levels in your blood. You might also have other checks like blood pressure, heart rate, and general health assessments.

While the exact number and length of visits aren't detailed, bioequivalence studies often involve staying overnight at a clinic for some portions, especially after taking the medication, so that samples can be collected regularly. You'll be carefully looked after by the medical staff throughout the study. After the last dose of medication and final assessments, there will likely be a follow-up check-up to ensure you are well. The total duration of your participation, from your first visit to your final follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is contributing to medical science, which could lead to simpler treatment options for people managing cholesterol in the future. You will also receive careful medical monitoring throughout your participation. Potential risks could include side effects from the medication, such as mild stomach upset, headache, or muscle aches, which are common with statins and similar drugs, though often mild. There's also the discomfort of blood draws and the time commitment involved. You will be fully informed of all potential side effects before deciding to participate. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your future 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 a 'bioequivalence' study?

It's a study to check if a new combined medicine works the same way inside your body as taking the individual medicines separately, ensuring it's just as effective.

Who can take part in this study?

Healthy men and women aged 18 or older can take part. You must be in general good health, without any specific medical conditions.

What kind of medicines are being tested?

The study is looking at medicines typically used to lower cholesterol: Bempedoic Acid, Ezetimibe, and Atorvastatin, either as separate pills or combined into one.

Will I have to stay overnight at a clinic?

Bioequivalence studies often involve some overnight stays at a clinic for blood tests and monitoring after taking the medication. The study team will provide full details.

What are the benefits of joining this study?

You'll contribute to developing possibly simpler cholesterol treatments and receive close medical monitoring. There's no direct personal health benefit for participants in this specific study.