Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

OPEN LABEL, FOUR-PERIOD, TWO-SEQUENCE, FULLY-REPLICATED, RANDOMIZED, SINGLE DOSE COMPARATIVE STUDY TO ASSESS BIOEQUIVALENCE OF Polypill AAR 100/80/10 mg capsules FIXED DOSE COMBINATION (TEST) VERSUS EQUAL DOSES OF COADMINISTERED Aspirin® N 100mg tablets + Cardyl® 80mg film-coated tablets + Acovil® 10mg tablets (REFERENCE formulations) IN HEALTHY MALE AND FEMALE VOLUNTEERS UNDER FASTING CONDITIONS

This study is looking at a new medication called Polypill AAR, which is a single capsule containing three medicines: aspirin, Cardyl, and Acovil. Instead of taking three separate tablets, this new capsule combines them into one. We want to find out if taking the Polypill AAR capsule has the same effect on your body as taking the three individual tablets at the same time. This is important to make sure the combined capsule works just as well and is absorbed in the same way. The study involves healthy adult volunteers and will check how the medicines are handled by your body when you take them without food. It's a key step to make sure the new combined capsule delivers the right amount of medicine safely.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Ferrer Internacional S.A.

Enrolment target

Start

20 Oct 2023

Study performed on healthy volunteers

What is this study about?

This study is about a new all-in-one capsule called Polypill AAR. Imagine having to take several different pills every day for a condition. What if you could take just one capsule instead? That's what Polypill AAR aims to do – it combines three commonly used medicines (Aspirin, Cardyl, and Acovil) into a single capsule.

The main goal of this particular study is to check if this new combined capsule delivers the medicines to your body in the exact same way as taking the three separate tablets individually. This is called a 'bioequivalence' study. Think of it like comparing two identical cars: they might look different on the outside (one combined, one separate), but we need to make sure they perform exactly the same under the bonnet – meaning the amount of medicine absorbed into your bloodstream and how quickly, needs to be identical. This reassures doctors and patients that switching to the combined capsule would provide the same health benefits as taking the separate pills.

This is a very early stage of testing, often called a 'Phase I' study. It's done with healthy volunteers, which means people who don't have any specific illnesses that might affect how their body handles the medicines. This helps researchers understand how the drugs work in a straightforward way before testing them in people with health conditions. The results from this study are vital for deciding if the Polypill AAR capsule can be used more widely.

Key takeaways

This study compares a new combined medicine capsule (Polypill AAR) with three separate tablets.
It aims to prove the new capsule works just as well as the individual tablets.
The study involves healthy adult men and women.
Participation includes taking medicines, blood tests, and health checks.
It's an important early step in developing new treatments.

Who may be eligible?

This study is open to healthy adult volunteers, both men and women. You must be at least 18 years old to take part, and there isn't an upper age limit mentioned.

Since this study involves healthy people, you shouldn't have any major medical conditions or be taking other medications that might interfere with the study drugs. The aim is to see how the investigational drugs are processed by the body on their own, without other health issues complicating things.

A thorough medical check-up will be carried out before you can join to make sure you are in good health and it's safe for you to participate.

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 comfortable with blood tests?
Are you able to follow specific instructions, such as fasting?
Are you able to attend multiple appointments at the study clinic?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will visit the study centre multiple times. You'll switch between taking the new Polypill AAR capsule and taking the three separate tablets. You will also participate in several fasting periods, meaning you won't eat for a certain amount of time before taking the medication.

Throughout the study, blood samples will be taken regularly after you've taken the medicine. These samples help the researchers measure how much of the medicine is in your bloodstream and how your body processes it. There will also be other health checks, like blood pressure and heart rate measurements, to ensure your safety. The total duration of your involvement in the study will be explained to you, including how many visits and overnight stays (if any) are required.

Potential risks and benefits

The main benefit of taking part in this type of study is helping advance medical science, potentially leading to new, more convenient ways for patients to take their medication in the future. You will also receive careful medical monitoring throughout the study. Potential risks are generally low in healthy volunteer studies but can include discomfort from blood draws, minor side effects from the medicines (like headache or upset stomach, similar to what you might get from regular aspirin), or allergic reactions. All potential side effects will be fully explained. 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
Romania

Common questions

What does 'bioequivalence' mean?

It means the study is checking if the new combination capsule delivers the same amount of medicine to your body, at the same speed, as taking the three separate tablets.

Why do I have to be healthy to join?

Researchers want to see how the medicines work in a straightforward way, without other health problems affecting the results. This helps them understand the drug's basic effects.

Will I know if I'm getting the new capsule or the separate pills?

This is an 'open label' study, which means you and the study team will know which treatment you are receiving at different times. However, the order in which you receive them will be chosen randomly.

What does 'fasting conditions' mean?

This means you will not eat for a certain period before taking the study medication. This helps researchers see how the medicine is absorbed without food interfering.

Will I be paid for taking part?

Many clinical trials, especially those involving healthy volunteers, offer compensation for your time and inconvenience. This will be discussed with you if you are interested.