Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence of Ruxolitinib 25 mg Tablets in Healthy Participants Under Fasting Conditions

This study is looking at a medication called ruxolitinib, which is used to treat certain blood and bone marrow conditions. We are testing a new version of the 25 mg tablet to see if it delivers the same amount of medicine to the body as the original tablet when taken by healthy people. This type of study, called a bioequivalence study, is important to make sure that different versions of a medicine work in the same way. Participants will be healthy adults, both men and women, aged 18 and older. They will take the tablets on an empty stomach, and researchers will measure how the medicine is absorbed and leaves their bodies. It's an early-stage study to gather important information about this new tablet.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Bluepharma Industria Farmaceutica S.A.

Enrolment target

Start

07 Mar 2025

No medical condition.

What is this study about?

This study is all about a medication called ruxolitinib. It's used for serious conditions that affect your blood and bone marrow. Think of it like this: if a company makes a popular toy, and then decides to make a slightly different version – maybe it's a different colour or made in a new factory – they need to make sure the new toy works exactly the same as the original. This is similar for medicines.

In this study, researchers want to check a new 25 mg tablet of ruxolitinib. They need to find out if this new tablet works in exactly the same way as the original one when it enters your body. This means checking if it gets absorbed at the same speed and to the same amount, and then leaves your body at the same speed. This process is called 'bioequivalence' – a fancy word meaning 'biologically equal'.

By doing this study, we can be confident that if you were to take this new tablet in the future, it would have the same effect as the original. This is a vital step in developing new medicines or new versions of existing ones, making sure they are safe and effective for people who need them.

Key takeaways

Tests a new ruxolitinib tablet in healthy adults.
Checks if the new tablet works the same as the original.
Participants must be 18+ and healthy.
Medicines taken on an empty stomach.
Involves clinic visits and blood tests.
Helps ensure medicines are safe and effective.

Who may be eligible?

This study is looking for healthy adults to take part. This means you shouldn't have any significant medical conditions or ongoing health problems. The aim is to understand how the medication works in a typical, healthy body, so other health issues could make the results unclear.

You must be at least 18 years old to be considered for this study. There is no upper age limit, meaning older adults who are otherwise healthy can also participate. Both men and women are welcome to take part.

More specific health checks will be done by the study team to make sure you are suitable. For instance, they'll check your general health, blood tests, and medical history to confirm you are truly healthy enough for the study.

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 with no ongoing medical conditions?
Are you comfortable with taking medication and having blood tests?
Are you able to follow specific instructions, like fasting?
Are you able to attend appointments at a study clinic?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given the ruxolitinib tablets on an empty stomach. This means you'll need to fast (not eat anything) before taking the medication, likely overnight. You will probably stay at a clinic for a short period after taking the medicine so that the study team can carefully monitor you and take blood samples at specific times.

These blood samples are very important. They help the researchers measure how much of the medication is in your body and how quickly it's absorbed and then leaves. You might have several visits or periods of staying at the clinic, and there could be follow-up appointments after you've finished taking the medication to make sure you're well. The total time you'd be involved in the study would be explained fully by the study team.

Potential risks and benefits

The main benefit of taking part in a study like this is contributing to medical science, which helps bring new or improved medicines to people who need them. For you personally, there's no direct health benefit, as you are healthy. Potential risks could include side effects from the medication, even though it's given to healthy people, or discomfort from blood draws. All known risks will be clearly explained by the study team. Remember, you can choose to leave 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 exactly is 'ruxolitinib'?

Ruxolitinib is a medicine used to treat certain blood and bone marrow disorders. This study is testing a new version of the tablet.

Why do you need healthy people for this study?

We need healthy people to see how the medicine works in a typical body without other health problems affecting the results. This helps us get clear information about the new tablet.

Will I get paid for taking part?

Payment for participation varies between studies. This would be explained in detail by the study team if you express interest.

Will I have to stay overnight anywhere?

It's likely you will need to stay at a clinic for a short period after taking the medicine, especially for the initial dose, so you can be monitored closely and have blood samples taken on schedule.

What does 'fasting conditions' mean?

This means you will be asked not to eat or drink anything (except water) for a certain number of hours before taking the study medication. This is to make sure the food doesn't affect how the medicine is absorbed.