Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A relative bioavailability study between a fixed dose combination product of Ibuprofen and Paracetamol vs. free combination of Ibuprofen and Paracetamol

This research study is investigating a new tablet that combines two common pain and fever medicines: ibuprofen and paracetamol. We're looking at how your body absorbs and uses these medicines when they're given together in one tablet, compared to taking ibuprofen and paracetamol as separate tablets. This is called a 'bioequivalence study' and it helps us understand if the new combination tablet works just as well and safely as taking the medicines individually. The study is for adults aged 18 and over who are generally healthy. It's an early-stage study, meaning we're focusing on how the medicine behaves in the body.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Biofarm S.A.

Enrolment target

Start

20 Nov 2024

cold and flu pain fever

What is this study about?

This study is about a new way to take two well-known medicines: ibuprofen and paracetamol. You might already use these for everyday problems like headaches, muscle aches, or when you have a cold or flu with a fever. Often, doctors suggest taking both medicines together for better relief.

Researchers have developed a single tablet that contains both ibuprofen and paracetamol. The main goal of this study is to see if your body uses the medicine from this new combination tablet in the same way it uses the medicine from separate ibuprofen and paracetamol tablets. We want to make sure that the amount of medicine that gets into your bloodstream, and how quickly it gets there, is similar for both options.

Understanding this is very important. It helps ensure that the new combination tablet will be just as effective and safe as taking the medicines separately for conditions like colds, flu, and general pain or fever. If the body handles them similarly, it could make it easier and more convenient for people to take their medication.

Key takeaways

Tests a new single tablet combining ibuprofen and paracetamol.
Compares how your body uses the combined tablet versus separate pills.
Aimed at adults aged 18 and over, in good general health.
Involves clinic visits and blood samples.
Helps ensure new medicines are effective and safe for cold, flu, pain, and fever.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old. Both men and women can take part.

Generally, participants in this type of study should be in good overall health. The aim is to understand how the medicine works in a healthy person's body, rather than how it interacts with other health conditions.

The research team will carry out some checks to make sure you're suitable and healthy enough to participate safely. They will explain everything clearly before you make any decisions.

Quick self-check

Are you 18 years old or older?
Are you generally healthy?
Are you able to visit the clinic for appointments?
Are you comfortable having blood samples taken?
Do you understand that you will be taking ibuprofen and paracetamol?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would visit the research clinic a few times. During these visits, you'll be given either the new combination tablet or separate ibuprofen and paracetamol tablets. The study team will then take blood samples at different times to measure how much of the medicine is in your body.

You might also have other checks, like having your blood pressure taken or giving urine samples. We expect you to stay at the clinic for certain periods to ensure your safety and that the measurements are accurate. The full duration of your involvement, including all visits and follow-up, will be explained in detail.

Potential risks and benefits

Taking part in a study has potential benefits, such as contributing to medical knowledge that could help future patients, and you will receive close medical supervision. However, there are also potential risks, like mild side effects from the medicines (which are generally well-known for ibuprofen and paracetamol) or discomfort from blood draws. You will be fully informed of all known risks before you decide to participate, and importantly, you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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Greece

Common questions

What is a 'bioequivalence study'?

It's a study to check if two different versions of a medicine, or two ways of taking it, deliver the same amount of the active ingredients to your body at the same speed. It makes sure new medicines work in a similar way to existing ones.

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

In some parts of the study, you might not know which treatment you are receiving until after results are collected. This helps make the study fair and accurate, but it will always be explained upfront.

Do I need to have a cold or flu to join?

No, you don't need to be ill. This study is testing how the medicine is absorbed in generally healthy people, not how it treats symptoms in sick people.

Will I get paid for taking part?

Many studies offer some payment or compensation for your time and travel. This will be discussed with you by the research team.

What happens if I feel unwell during the study?

The research team will be on hand to monitor you closely. If you feel unwell at any point, you should tell them immediately, and they will provide medical care as needed.