Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Randomised, crossover bioequivalence clinical trial of ezetimibe/atorvastatin 10 mg/80 mg tablets versus ezetimibe/atorvastatin 10 mg/80 mg film-coated tablets, after a single oral dose administration to healthy volunteers under fasting conditions

This research is a study for healthy volunteers to compare two forms of a common heart medication that contains two active drugs: ezetimibe and atorvastatin. These medications are often used together to lower cholesterol. We want to find out if a new tablet version of this combined medication is absorbed and used by the body in the same way as the current, well-known tablet (ATOZET). This is important to make sure any new version of the medicine works just as well and is safe for patients. By checking how much of the medication gets into the bloodstream and how quickly, we can confirm they are equivalent.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Normon S.A.

Enrolment target

Start

23 Jun 2023

Healthy volunteers

What is this study about?

This study is all about understanding how your body handles medicines. Specifically, we're looking at a combination drug that contains ezetimibe and atorvastatin. These two medicines are often prescribed together to help lower cholesterol levels in people. This can be really important for preventing heart problems.

Think of it like this: if you buy a new brand of your favourite snack, you'd want to make sure it tastes exactly the same as the old one. In the world of medicine, it's even more important to know that different versions of a drug work identically. This study is doing just that – comparing a new version of the combined ezetimibe/atorvastatin tablet with the established one (called ATOZET).

The main goal is to see if your body absorbs and uses both tablets in the same way. This is known as 'bioequivalence'. If they are bioequivalent, it means doctors can be confident that the new version will be just as effective and safe as the original for patients who need it. It helps ensure that everyone gets the best possible treatment.

Key takeaways

Compares two versions of a common cholesterol-lowering medication (ezetimibe/atorvastatin).
Aims to ensure new versions work the same as existing ones.
Looking for healthy adult volunteers, both men and women.
Involves taking medication and giving blood samples.
Participation helps future patients get effective treatment.

Who may be eligible?

This study is looking for healthy adults. To be considered, you must be at least 18 years old – there's no upper age limit, as long as you are otherwise healthy.

Both men and women are welcome to take part in this study. The most important thing is that you are in good general health, and your doctor agrees that you are suitable to participate.

The research team will carry out some checks to make sure the study is a good fit for you and that taking part would be safe. They will ask about your medical history and current health.

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?
Are you able to attend clinic visits for blood tests?
Are you willing to take a study medication?
Are you comfortable with abstaining from food for a period before taking the medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be considered a 'healthy volunteer'. The study involves taking a single dose of two different versions of the ezetimibe/atorvastatin medication at different times. This means you will receive one version on one day, and after a break, you'll receive the other version.

Throughout the study days, you'll have several blood samples taken. This is to measure how much of the medication is in your system and how your body processes it. You'll likely need to stay at a research clinic for a period after each dose for these samples to be collected. There will also be a follow-up to ensure you are well after the study is complete. The total duration of your participation will include these study days and a final check-up.

Potential risks and benefits

Potential benefits of participating include contributing valuable information that helps medical science and future patients access effective medicines. You may also receive some payment for your time and inconvenience. Potential risks could include mild side effects from the medication, such as stomach upset or muscle aches, or discomfort from blood samples. The research team will carefully monitor you for any side effects. You are free 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
Spain

Common questions

What kind of medication is being studied?

We are studying a combination of two medications, ezetimibe and atorvastatin, which are used to lower cholesterol.

What does 'bioequivalence' mean?

It means we are checking if two different versions of the same medicine are absorbed and used by the body in exactly the same way.

Do I have to take both medicines?

You will take both versions of the combined ezetimibe/atorvastatin tablet, but at different times, not simultaneously.

Will I get paid for taking part?

Compensation for your time and travel is usually provided for healthy volunteer studies, but the exact amount will be discussed with you.

Who are 'healthy volunteers'?

Healthy volunteers are people who are generally in good health and don't have major medical conditions that would affect the study results.