Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Study to compare drug availability in the bloodstream of two oral formulations of dexketoprofen in healthy volunteers under fasting conditions.

This study is investigating two slightly different versions of a pain relief medicine called dexketoprofen. Doctors want to understand how well and how quickly each version is absorbed into the bloodstream when taken by healthy people who haven't eaten recently. This type of research, known as a bioequivalence study, helps ensure that new versions of existing medicines work just as effectively and safely as the original. By comparing the two forms, scientists can confirm they deliver the same amount of the drug to the body. This is a very early-stage study, focusing on understanding how the medicine behaves in the body.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Faes Farma S.A.

Enrolment target

Start

06 Feb 2026

Bioequivalence clinical trial in healthy volunteers under fasting conditions.

What is this study about?

Imagine you have a headache and take a painkiller. This study is all about making sure that if a company makes a slightly different version of that same painkiller, it will work just as well as the original one. We're looking at a specific pain relief medicine called dexketoprofen.

Researchers want to see exactly how much of the medicine gets into the body and how quickly, comparing two different ways it's given. This is important because even small changes in a medicine can affect how it works. By doing this study, we can be confident that patients will get the right amount of medicine, whether it's the original or a generic version.

This kind of study is called a 'bioequivalence' study. It's a key step in developing medicines, helping to show that different versions are effectively the same for your body. It helps ensure that new options for medicines are both safe and work as expected.

Key takeaways

Compares two forms of a common painkiller.
Checks how much medicine gets into the bloodstream.
Looks for healthy adult volunteers (ages 18+).
Requires fasting before taking the medicine.
Helps ensure medicines work as expected and are safe.
Involves clinic visits and blood tests.

Who may be eligible?

This study is looking for healthy adults to take part. You must be at least 18 years old – there's no upper age limit, as long as you are healthy. Both men and women are welcome.

Because this is a study for healthy volunteers, you shouldn't have any major ongoing health problems. The aim is to see how the medicine works in a typical healthy body.

Specific details about other health conditions, medications you might be taking, or if you smoke or drink, would be discussed with the study team to check if you're a good fit.

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 healthy?
Are you comfortable having blood samples taken?
Can you commit to attending clinic visits?
Are you able to fast (not eat/drink) for specific periods?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive doses of the study medicine. You would need to attend the study clinic for various visits. During these visits, the study team would take blood samples at specific times to measure how much of the medicine is in your bloodstream. You would also have regular health checks, like measuring your blood pressure and heart rate.

For some parts of the study, you would need to fast, meaning you wouldn't be allowed to eat or drink anything (except water) for a certain number of hours before taking the medicine. The total length of your involvement in the study would require several visits over a period of time, which the study team would explain in detail. Each visit's length would vary depending on the blood tests and observations needed.

Potential risks and benefits

Participating in a study like this might offer a small payment for your time and inconvenience. The main benefit is helping advance medical knowledge, which can lead to better medicines for everyone. However, there are potential risks, similar to taking any medicine. You might experience side effects from the dexketoprofen, such as stomach upset, dizziness, or headache. The study team will closely monitor you for any side effects. 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
Czechia

Common questions

What is dexketoprofen?

Dexketoprofen is a medicine used to relieve pain, similar to ibuprofen or aspirin.

Why do you need healthy volunteers?

We study healthy volunteers first to understand how the medicine works in a typical body without other health problems affecting the results.

What does 'fasting conditions' mean?

It means you won't eat or drink anything (other than water) for a set time before taking the medicine, to see how it's absorbed without food interference.

Will I know if I'm getting the old or new version of the drug?

For these types of studies, sometimes the participant or even the researchers don't know to keep the results unbiased. This would be explained before you join.

Will taking part affect my regular doctor's care?

No, taking part in a clinical trial should not affect your relationship with your usual doctor or any care you receive from them.