Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence clinical trial of two formulations of rosuvastatin.

This research is a 'bioequivalence' clinical trial. This means scientists are comparing two different versions of a medicine called rosuvastatin, which is used to treat high cholesterol. They want to check if the new version works just as well as the original by seeing if it's absorbed and used by the body in the same way. This is an early-stage study, open to adults aged 18 and over, regardless of their gender. The aim isn't to cure your cholesterol but to gather important information about how medications work. Taking part helps ensure new medicines are safe and effective for everyone.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Alter S.A.

Enrolment target

Start

17 Feb 2026

Hypercholesterolemia

What is this study about?

This study is called a 'bioequivalence' trial. In simple terms, this means researchers are comparing two different versions of the same medicine. Imagine you have a branded crisp and a supermarket's own-brand crisp – they might look slightly different, but the supermarket wants to make sure their crisp tastes and performs just as well. In this medical study, they're doing something similar with a medicine called rosuvastatin, which is commonly used to help lower high cholesterol.

Rosuvastatin is a well-known drug for people who have high levels of cholesterol in their blood. High cholesterol can increase your risk of heart problems, so medicines like rosuvastatin are important for many people. The main goal of this particular study is to see if a newer version of the rosuvastatin tablet is absorbed into the bloodstream and acts in the body in the same way as an already approved version. This is crucial because it helps ensure that if a new version of a medication is released, it will be just as effective and safe for patients as the original.

This kind of research is a very early step in bringing medicines to patients. It helps medical regulators, like the MHRA in the UK, make sure that any new or generic versions of medicines meet strict quality and performance standards. By participating, you would be helping contribute to the overall safety and effectiveness of medicines available to the public.

Key takeaways

This study compares two versions of a cholesterol medicine (rosuvastatin).
It checks if the medicines are absorbed similarly by the body.
Open to adults aged 18 and over, both men and women.
Participation helps ensure new medicines are safe and effective.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. There is no upper age limit, so older adults can also be considered.

The study is open to both men and women. If you have high cholesterol, this study might be suitable for you.

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?
Do you have high cholesterol?
Are you able to commit to several study visits?
Are you happy to have blood samples taken regularly?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll mainly be helping researchers understand how the different versions of rosuvastatin are absorbed by your body. This usually involves spending some time at a research clinic. You'll be given one of the rosuvastatin medications, and then the research team will take blood samples over several hours to measure how much of the medicine is in your system at different times. This process will typically be repeated at a later date, where you would receive the other version of the medicine.

During your visits, doctors and nurses will monitor your health closely. The total time you'd be involved in the study, including all visits and follow-up, would be discussed with you in detail before you agree to join. You won't be expected to manage your cholesterol during this study; the focus is purely on how your body handles the medicine.

Potential risks and benefits

The main benefit of taking part in this study is contributing to medical science, which helps ensure that new versions of existing medicines are safe and work effectively for future patients. You won't directly benefit from treating your high cholesterol during the study, as the focus is on medication absorption. Potential risks could include side effects from the rosuvastatin, such as muscle pain or stomach upset, though these are generally well-known for this medicine. There might also be discomfort from blood samples. 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
Spain

Common questions

What is rosuvastatin?

Rosuvastatin is a medicine commonly prescribed to help lower high levels of cholesterol in the blood, which can reduce the risk of heart disease.

What does 'bioequivalence' mean?

It means the study is comparing two different versions of the same medicine to ensure they work in exactly the same way in your body.

Will this study treat my high cholesterol?

The main goal of this study is not to treat your cholesterol, but to gather information about how specific medications are absorbed. Your own cholesterol treatment would typically be managed by your regular doctor.

Do I have to be male or female to join?

No, this study is open to both men and women who meet the other requirements.

How long will I be involved if I join?

The exact duration would be explained by the study team, but these types of studies often involve several visits over a few weeks or months.