Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

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

This study is a type of research called a 'bioequivalence study'. It's designed to see if a new combination pill, which contains medicines for high cholesterol (bempedoic acid, ezetimibe, and atorvastatin), works in the same way your body when taken as separate tablets. We want to make sure the combination pill delivers the right amount of medicine to your bloodstream and that it's absorbed at the same speed. This type of study is important for making sure new medicines are safe and effective before they become widely available. It involves healthy adult volunteers and helps us understand how these medicines act when combined.

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 sometimes take several different pills for the same health issue. What if you could take just one pill that combines all those medicines? This study is looking at exactly that scenario for medicines used to manage high cholesterol. Scientists have created a new pill that combines three different medicines: bempedoic acid, ezetimibe, and atorvastatin.

This research is called a 'bioequivalence study'. In simple terms, 'bioequivalence' means checking if the new combination pill does the same job in your body as taking each of those three medicines separately. We want to know if the combination pill delivers the same amount of medicine into your bloodstream, and if it does so at the same speed. This is really important to make sure the combination pill is as effective and safe as the separate tablets you might already be taking.

This study is in an early stage, which we call 'Human Pharmacology' or 'Phase I'. This means we're carefully observing how the new medicine behaves in healthy people. The findings from this study will help regulators decide if the combination pill can be approved for wider use to help people who need to manage their cholesterol levels.

Key takeaways

This study compares a new combined cholesterol pill with taking individual pills.
It aims to see if both methods work equally well in your body.
It's an early-stage study involving healthy adults.
Participation helps develop new ways to manage cholesterol.
You'll receive close medical supervision if you take part.

Who may be eligible?

This study is looking for healthy adults. You don't need to have any particular health conditions to take part. In fact, it's really important that you are generally well and not taking many other medicines.

Both men and women are welcome to participate. You need to be at least 18 years old – there's no upper age limit, as long as you meet the other health requirements.

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?
Do you not have any major medical conditions?
Are you able to attend several clinic visits?
Are you comfortable potentially taking new medication as part of a study?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to a clinic. You would be given either the new combination pill or the individual tablets, and doctors would closely monitor your health. This would include having blood tests to see how the medicine is absorbed and leaves your body, as well as regular check-ups.

Before you start, there would be a screening visit to make sure you're suitable. Once you're in the study, you'd be asked to take the study medication as instructed. There would likely be follow-up appointments after you take the medication to ensure everything is well. The total time commitment for the study would be explained to you in detail before you decide to take part.

Potential risks and benefits

The main benefit of taking part in a study like this is contributing to medical science and helping to develop new, potentially more convenient, medicines for others. You might also receive expert medical care and monitoring during the study. As with all medicines, there can be risks, such as side effects from the study medication, though these will be carefully explained to you. 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 does 'bioequivalence' mean?

It means checking if a new medicine (like a combination pill) works exactly the same way in your body as an existing one, delivering the same amount of medicine at the same speed.

Why is this study only looking for healthy people?

In early-stage studies like this, using healthy volunteers helps researchers understand how the medicine behaves without other health conditions making it complicated to interpret the results.

Will I get paid to participate?

The study information doesn't specify, but often, healthy volunteer studies offer some payment for your time, travel, and inconvenience. You should ask the study team about this.

What is 'Phase I' of a clinical trial?

Phase I is the first step where a new medicine is tested in people. It mainly focuses on safety and how the body handles the medicine, often using a small group of healthy volunteers.

What are bempedoic acid, ezetimibe, and atorvastatin for?

These are all different medicines that are used to help lower high cholesterol levels in the blood.