Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence of Tofacitinib 10 mg Film-Coated Tablets in Healthy Subjects Under Fasting Conditions.

This research study is looking at a new version of a medicine called Tofacitinib, which is used to treat conditions like arthritis. The main goal is to make sure this new tablet works exactly the same way as the original medicine. To do this, healthy volunteers will take a single dose of the new tablet on an empty stomach. Researchers will then closely monitor how the medicine is absorbed into their bodies. Think of it like comparing two different brands of a common painkiller – this study makes sure they both deliver the same amount of active medicine into your system. This is a very early stage study, focused purely on understanding how the body handles the medicine, rather than treating a specific illness.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Bluepharma Industria Farmaceutica S.A.

Enrolment target

Start

21 Nov 2023

No medical condition.

What is this study about?

This study is all about making sure new medicines are just as good as the ones we already have. Imagine a brand new car model comes out – you'd want to know it's just as safe and reliable as the old one, wouldn't you? In this study, scientists are testing a new version of a medicine called Tofacitinib. This drug is often used to help people with conditions like rheumatoid arthritis, but this study isn't about treating illness.

The main purpose is to see how the new version of the Tofacitinib tablet behaves in the body compared to the original. This is called a 'bioequivalence' study. It means checking if the body absorbs the medicine in the same amount and at the same speed. If it does, doctors can be confident that the new version will work just as effectively for patients.

By taking part, healthy volunteers help ensure that future medicines, or new versions of existing ones, are developed safely and effectively for everyone in the UK. It's a crucial step in bringing new and improved treatments to people who need them.

Key takeaways

This study checks if a new version of a drug (Tofacitinib) works the same way as the original.
It's for healthy adults, not people with an illness.
Participation involves taking a single tablet on an empty stomach and having blood samples taken.
Your involvement helps ensure future medicines are safe and effective.
You can leave the study at any time.

Who may be eligible?

This study is looking for healthy adults to take part. To be considered, you must be 18 years old or older. There is no upper age limit, meaning older adults are welcome too. Both men and women can participate in this research.

It's really important that you don't have any significant health problems. This study needs people who are generally well, as it helps the researchers see exactly how the medicine acts in a healthy body, without other health issues making it complicated.

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 and feel well?
Are you able to follow study instructions, including fasting?
Are you comfortable with regular blood tests?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be asked to take one Tofacitinib tablet. This will happen when you haven't eaten anything for a while (fasting). After you take the tablet, the research team will regularly take small blood samples to see how the medicine is processed by your body. You'll likely need to stay at the study site for a number of hours, or perhaps even overnight, for these checks.

There might be a few clinic visits involved, including an initial screening to make sure you're suitable, the main study day, and possibly a follow-up visit. The total time you'll spend participating in the study, from your first visit to your last, will be explained fully by the study team. They will also let you know exactly what medical tests, like blood pressure checks and blood tests, will be done.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For this specific study, you won't directly benefit from treatment as you'll be healthy and not needing the medicine. However, you'll be contributing to scientific knowledge, helping to ensure new medicines are safe and effective for future patients. Potential risks might include discomfort from blood draws, slight bruising where blood was taken, or very rare side effects from the study drug itself, which are generally mild in healthy individuals. 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
Portugal

Common questions

What is Tofacitinib?

Tofacitinib is a medicine used to treat certain conditions like rheumatoid arthritis, but in this study, it's being given to healthy people to understand how it works in the body.

Why do you need healthy people for this study?

Healthy volunteers help researchers understand exactly how the medicine is absorbed and processed by the body without other illnesses making the results unclear.

Will I get paid for taking part?

Often, studies like this offer payment for your time and inconvenience. The study team will be able to give you specific details about this.

How long will I need to stay at the clinic?

You will likely need to stay for several hours, or even overnight, on the day you take the medicine so researchers can take blood samples at specific times. The exact duration will be explained by the study team.

What does 'fasting conditions' mean?

Fasting means you cannot eat or drink anything (other than water) for a certain period of time, usually overnight, before you take the medicine in the study.