Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Randomised, bioequivalence clinical trial of atorvastatin 80 mg capsules vs atorvastatin 80 mg film-coated tablets, after a single oral dose administration to healthy volunteers under fasting conditions in crossover replicated design.

This research is looking at two forms of a common cholesterol-lowering medicine called atorvastatin 80 mg. Specifically, it wants to find out if the body absorbs the same amount of medicine from a capsule as it does from a film-coated tablet. This is important to make sure that both forms of the medication work effectively. Healthy adult volunteers will take part in this study, which involves taking each type of medicine under careful supervision to compare how they work in the body. The goal is to ensure that patients get consistent treatment, whether they take the capsule or the tablet.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Alter S.A.

Enrolment target

Start

24 Jun 2024

Hypercholesterolaemia Prevention of cardiovascular disease

What is this study about?

This study is about a very common medicine called atorvastatin. You might know it as a statin. It's often prescribed to help lower high cholesterol, which can be a risk factor for heart and blood vessel problems like heart attacks and strokes. This research wants to make sure that different versions of this medicine work in the same way.

Specifically, the researchers are comparing an 80 mg atorvastatin capsule with an 80 mg atorvastatin tablet. They want to check if, when you take them, your body absorbs the same amount of the active medicine from both. This is called 'bioequivalence'. If two medicines are bioequivalent, it means they are expected to have the same effect in your body.

This kind of study is really important for medicines that are already widely used. It helps ensure that if a different form of the medicine becomes available (like a capsule instead of a tablet, or vice versa), patients will still get the same safe and effective treatment. It’s all about making sure medicines work consistently, no matter their exact form.

Key takeaways

This study compares an atorvastatin capsule with a tablet.
It aims to see if both deliver the same amount of medicine.
Healthy adult volunteers are needed for participation.
The study involves taking both forms of medicine and blood tests.
It helps ensure consistent medicine effectiveness for patients.

Who may be eligible?

To join this study, you need to be a healthy adult. This means you generally don't have any major ongoing health problems.

Participants must be at least 18 years old. There isn't an upper age limit mentioned, but you'll need to be fit enough to take part safely.

Both men and women can join this study. The medical team will check your health carefully to make sure the study is a good fit 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?
Are you generally in good health?
Are you willing to fast (not eat) before taking the medicine?
Are you comfortable with having blood samples taken regularly?
Are you able to commit to several clinic visits?

Answer every question to see your result.

What does participation involve?

If you take part, you'll be given either the atorvastatin capsule or the tablet first, and then after a break, you'll be given the other form. This is known as a 'crossover' design, meaning you'll get both types of medicine at different times.

Each time you take the medicine, you'll need to do so after not eating for a certain period (fasting). Researchers will then regularly take blood samples to measure how much of the medicine is in your body over time. This helps them compare how the capsule and tablet are absorbed.

The study will involve several visits to the clinic for these measurements. The total duration of your involvement, including all visits and breaks between taking the different medicines, will be explained to you before you agree to take part.

Potential risks and benefits

The main benefit of taking part is contributing to important medical research that helps ensure medicines are safe and effective for everyone. You won't directly benefit from taking the medicine as you are a healthy volunteer. As with any medicine, there's always a small chance of side effects, but these will be carefully monitored. The study will be conducted under strict medical supervision to minimise any risks. 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 atorvastatin?

Atorvastatin is a medicine often called a 'statin'. It's used to lower high cholesterol levels in the blood, which can help prevent heart disease and strokes.

Why are you comparing a capsule and a tablet?

We want to make sure that both the capsule and tablet versions of atorvastatin 80 mg deliver the same amount of medicine to your body, meaning they should work in the same way.

Will I get both the capsule and the tablet?

Yes, you will take both the capsule and the tablet, but at different times during the study, with a break in between. This helps us compare them directly in the same person.

Do I need to be ill to join?

No, this study is looking for healthy adult volunteers. You should not have the conditions that atorvastatin usually treats (like high cholesterol).

What does 'fasting conditions' mean?

It means you will need to avoid eating or drinking (except water) for a certain number of hours before taking the study medicine on specific days.