Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence clinical trial of two formulations of ezetimibe/atorvastatin

This research study is comparing two different versions of a medicine called ezetimibe/atorvastatin. This particular medicine is commonly prescribed to help people lower their cholesterol levels. The main goal is to see if a newer version of this medicine works in the body in the same way as an older, well-known version. This is important to make sure that patients receive a medicine that is effective and safe, no matter which version they take. We are looking for healthy adults to volunteer for this study. By taking part, you would be helping medical science ensure that medicines are reliable for everyone who needs them.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Normon S.A.

Enrolment target

Start

18 Feb 2025

Healthy volunteers

What is this study about?

This study is focused on a very common type of medicine called ezetimibe/atorvastatin. You might know it as a 'cholesterol-lowering' drug. When a company makes a new version of an existing medicine, or a generic version, they need to show that it works just as well as the original. This is where 'bioequivalence' comes in.

'Bioequivalence' simply means that two versions of a medicine deliver the same amount of the active ingredient to the body’s bloodstream at the same rate. This is really important because it means that patients will get the same treatment effect, whether they take the branded medicine or a new generic version. This helps ensure that all patients have access to effective medicines.

By taking part in this study, healthy volunteers help scientists confirm that the new version of ezetimibe/atorvastatin is just as good, safe, and effective as the established one. This kind of research is a crucial first step before new medicines or new versions of medicines can be widely used in healthcare.

Key takeaways

This study compares two versions of a common cholesterol-lowering medicine.
It aims to ensure new versions work as well as older ones ('bioequivalence').
Healthy adult volunteers are needed for this research.
Participation involves taking the medicine and giving blood samples.
Your involvement helps ensure safe and effective medicines for everyone.

Who may be eligible?

To join this study, we are looking for adults who are generally healthy. This means you shouldn't have any major ongoing health conditions or be taking lots of other medications that might affect the results of the study.

We welcome both men and women to participate. The study is open to adults aged 18 and over, with no upper age limit specified, providing you are otherwise healthy.

The health team will conduct a thorough check-up to make sure this study is safe and appropriate for you before you can take part.

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, without serious ongoing medical conditions?
Are you taking too many other medicines that might affect the study?
Are you able to attend several study visits, possibly including overnight stays?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would visit a clinical research centre for several appointments. During these visits, you’d receive doses of the study medication (the ezetimibe/atorvastatin). We would need to take blood samples regularly to see how the medicine is absorbed and processed by your body. You might also have other routine health checks like blood pressure measurements.

This is generally a short-term study, often involving a few overnight stays or multiple day visits spread out over a few weeks. The total duration of your involvement, including all visits and follow-ups, would be explained to you in detail before you agree to participate.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. There isn't a direct health benefit to you as a healthy volunteer, but you'll be contributing significantly to medical knowledge, which helps ensure medicines are safe and effective for others. Potential risks might include discomfort from blood draws, or side effects from the medication, though these are typically mild for this type of research. You will be closely monitored by medical staff, and you are free 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
Spain

Common questions

What is ezetimibe/atorvastatin?

It's a medicine often prescribed to help lower high cholesterol levels in the blood.

What does 'bioequivalence' mean?

It means two versions of a medicine act the same way in the body – delivering the same amount of drug at the same speed.

Do I have to be sick to join?

No, this study specifically needs healthy volunteers, as we are testing how the medicine works in a typical body.

How long will the study last if I join?

The exact length will be explained by the study team, but these types of studies usually involve a few visits over several weeks.

Will I get paid for taking part?

Many healthy volunteer studies offer compensation for your time and travel, which would be discussed before you agree to participate.