Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

OPEN-LABEL PALATABILITY STUDY OF A NOVEL ORODISPERSIBLE PARACETAMOL/IBUPROFEN FORMULATION AFTER A SINGLE ORAL ADMINISTRATION IN HEALTHY SUBJECTS

Imagine a new pain relief medicine that combines paracetamol and ibuprofen, but instead of a pill, it dissolves quickly in your mouth. This study is all about finding out how pleasant this new mouth-dissolving medicine tastes and feels to take. It involves healthy adult volunteers who will try a single dose of the new medicine. The researchers want to understand if it's easy and appealing to take, which is really important for a medicine designed this way. This is an early stage of testing, focusing purely on the experience of taking the medicine, not its effects on pain. It helps drug developers make sure new medicines are user-friendly from the start.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Farmalider S.A.

Enrolment target

Start

14 Jan 2026

Healthy volunteers

What is this study about?

This study is looking at a brand-new way to take two common pain relief medicines, paracetamol and ibuprofen, together. Instead of taking separate pills, this new form is designed to dissolve in your mouth very quickly. The main goal of this particular study is quite simple: to find out if this new medicine tastes good and is easy and pleasant to take. They call this 'palatability'.

Think about how some medicines can taste or feel unpleasant, making them hard to swallow. If a medicine is going to be helpful, people need to be able to take it without a fuss. So, researchers give a single dose of this new mouth-dissolving medicine to healthy adults and ask them about their experience, particularly focusing on the taste, texture, and overall feel of taking it.

This is an early step in developing new medicines. It's not about how well it treats pain yet, but about making sure the medicine is acceptable and easy for people to use. It's important foundational work to help create more user-friendly medications in the future. By gathering feedback on taste and feel early on, they can make improvements before the medicine goes into larger studies.

Key takeaways

It's a study for healthy adults.
The focus is on how a new paracetamol/ibuprofen medicine tastes and feels to take.
It's an early stage of testing for a mouth-dissolving formulation.
You would only take a single dose of the medicine.
The study helps develop more user-friendly medicines.

Who may be eligible?

This study is looking for healthy adults to take part. To be considered, you must be at least 18 years old. There isn't an upper age limit mentioned, so older adults can also be considered as long as they are healthy.

Both men and women are welcome to participate in this research. The most important thing is that you are generally healthy, as this study is not designed for people with existing medical conditions.

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 at least 18 years old?
Are you generally healthy?
Are you comfortable trying a new medicine?
Can you attend a single clinic visit?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would attend a clinic visit where you'll be given a single dose of the new mouth-dissolving paracetamol/ibuprofen formulation. Researchers will then ask you questions about your experience, focusing on how it tasted and felt to take. You won't be on this medication for a long time; it's just one dose to gather immediate feedback. There won't be ongoing follow-up visits or long-term medication to take. The total time commitment for this study would be quite short, likely just one visit.

Potential risks and benefits

A potential benefit of taking part is contributing to medical research that could lead to new, easier-to-take pain relief options. You might also receive a small payment for your time. Potential risks are generally low in this type of early study, but could include mild side effects from the medication, such as an upset stomach, although rare with a single dose in healthy people. You will be closely monitored, and 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 'open-label'?

Open-label means that both you and the study team will know exactly what medicine you are taking.

What does 'orodispersible' mean?

Orodispersible means the tablet dissolves quickly in your mouth, often without needing water.

Will this study help my pain?

This study is not designed to treat pain. Its main purpose is to test the taste and feel of a new medicine, not its pain-relieving effects.

Will I have to stay overnight?

No, this study only involves a single visit and does not require an overnight stay.

Who is paying for this study?

Typically, pharmaceutical companies or research organisations fund these types of studies.