Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Comparative Bioavailability of Ruxolitinib 20 mg Film-Coated Tablets in Healthy Participants Under Fasting Conditions.

This research study is about a medicine called ruxolitinib. It's designed to see how well a new tablet version of this medicine gets into the body when taken on an empty stomach. We're looking for healthy adults, aged 18 or older, to take part. This type of study, called a bioequivalence study, is important because it helps ensure that a new form of a medicine works just as effectively and safely as the original. Participants won't have any medical conditions, as the study needs to accurately measure how the medicine behaves in a healthy person. It's a key step in developing new medicines to make sure they are reliable for patients.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Bluepharma Industria Farmaceutica S.A.

Enrolment target

Start

20 Dec 2023

No medical condition.

What is this study about?

Imagine you have a favourite biscuit that comes in a round shape, and then a new square version is made. You'd want to be sure the square one tastes just as good and has the same amount of chocolate chips, right? This study is a bit like that, but for medicine.

The medicine in question is called ruxolitinib. Doctors prescribe it for certain conditions, but this study isn't looking at its benefits for those conditions. Instead, it's focusing on a new tablet form of the medicine. The aim is to check if this new tablet delivers the medicine into the body in the same way as the original version.

This kind of research is called a 'bioequivalence' study. 'Bio' refers to the body, and 'equivalence' means 'the same.' So, we're making sure the new tablet is just as good, or 'equivalent,' at getting the medicine into your system. This is a very early stage of drug development (Phase I), where we confirm that the building blocks of a medicine are working correctly before it's used more widely. It's a crucial step to ensure patients get reliable and effective treatments.

Key takeaways

Tests a new tablet form of a medicine called ruxolitinib.
Involves healthy adult volunteers, aged 18 or older.
Aims to check if the new tablet works just like the original.
Participants will take medicine on an empty stomach.
Blood samples will be taken to see how medicine moves through the body.
Contributes important information for future medicine development.

Who may be eligible?

This study is specifically looking for healthy adults. You won't be eligible if you have any ongoing medical conditions, as the study needs to see how the medicine works in people without other health issues.

To join, you need to be at least 18 years old. There's no upper age limit, meaning older adults are welcome too, as long as they are generally healthy.

Both men and women can participate in this study. The most important thing is that you are in good health and don't have any illnesses that could affect how your body handles the medicine.

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?
Do you consider yourself generally healthy, without any long-term medical conditions?
Are you able to follow study instructions, like fasting?
Are you happy to have blood samples taken?
Are you available for multiple clinic visits over a period?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the study medicine, ruxolitinib, on an empty stomach. This means you'll need to fast (not eat anything) before coming to the study centre. Researchers will then take blood samples at specific times to measure how much of the medicine is in your body and how quickly it's absorbed and processed.

There might be several visits to the clinic over a period, often including an overnight stay or extended day visits. During these visits, doctors and nurses will also check your overall health, such as your blood pressure and heart rate, to make sure you're doing well. The full duration of your involvement, including all visits and follow-up checks, will be explained to you before you agree to join.

Potential risks and benefits

The main benefit of taking part is contributing to medical science, which helps bring new and reliable medicines to people who need them. There's no direct health benefit to you from receiving this specific medicine, as you are healthy. Potential risks could include minor discomfort from blood draws, temporary side effects from the medicine (though it's given to healthy people in controlled settings), or inconvenience from the study visits. 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
Portugal

Common questions

What is ruxolitinib?

Ruxolitinib is a medicine used to treat certain blood problems. However, in this study, we're not giving it for any medical condition, but just to see how a new tablet form works in healthy people.

Why do I need to be healthy to join?

Being healthy helps us clearly see how the medicine is absorbed and processed by the body, without other health conditions affecting the results. It's like a clear test track for the medicine.

What does 'on an empty stomach' mean?

It means you won't be allowed to eat or drink anything (except water) for a certain number of hours before taking the study medicine. This is because food can sometimes change how a medicine is absorbed.

Will I get paid for taking part?

Often, studies like this offer some payment or compensation for your time and travel, as a thank you for your participation. This will be explained to you before you join.

How long will the study last for me?

The total time you'll spend participating, including all visits and follow-ups, will be clearly explained by the study team. It can vary but typically involves several clinic visits over a few weeks.