Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence of Tofacitinib 10 mg Film-Coated Tablets versus Xeljanz® 10 mg Film-Coated Tablets in Healthy Subjects Under Fasting Conditions

This study, called a bioequivalence study, is looking at a new 10mg tablet of a medicine called tofacitinib. Researchers want to make sure this new tablet acts exactly the same in your body as the well-known Xeljanz® 10mg tablet. This is a common and important step when new versions of medicines are developed. It means checking that the new tablet releases the medicine at the same speed and to the same extent as the original one. Participants will be healthy adults, and they won't have any medical conditions. The study is a "Phase I" study, meaning it's one of the first steps in testing a new medicine, focusing on how it behaves in human bodies.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Bluepharma Industria Farmaceutica S.A.

Enrolment target

Start

14 May 2024

No medical condition

What is this study about?

Imagine you have two identical keys, but one is made by a different company. This study is a bit like checking if the new key still opens the same lock just as effectively as the original one. In our case, the 'keys' are two different 10mg tablets of a medicine called tofacitinib. One is the familiar Xeljanz® tablet, and the other is a new version.

The main goal is to see if this new tofacitinib tablet behaves in exactly the same way in the body as the Xeljanz® brand. This check is called 'bioequivalence.' It means scientists will measure how much of the medicine gets into your bloodstream and how quickly, to make sure the new tablet performs identically to the existing one. This is a really important step to make sure any new medicine-like products are just as safe and work just as well as the original.

This type of study is routine when a new company wants to make a copy of an existing medicine, often called a generic version. It ensures that patients who might use the new tablet will get the same treatment benefit as those using the original. It's all about patient safety and making sure that new medicines are reliable.

Key takeaways

This study compares a new medicine tablet with an existing one to ensure they work the same.
It's for healthy adults, aged 18 or over.
No medical conditions are required to participate.
Participation involves taking tablets and giving blood samples.
The study helps ensure new medicines are safe and effective for future patients.

Who may be eligible?

This study is looking for healthy adults. You won't need to have any specific medical problems to take part – in fact, it's important that you don't have any major ongoing health conditions.

To be eligible, you need to be at least 18 years old. There isn't an upper age limit mentioned, so older adults could also be considered if they are otherwise healthy. Both men and women are welcome to participate in this 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?
Do you consider yourself generally healthy?
Do you not have any major ongoing medical conditions?
Are you able to attend several clinic visits?

Answer every question to see your result.

What does participation involve?

The study involves a series of visits to a clinic. You'll switch between taking the new tofacitinib tablet and the Xeljanz® tablet, usually with a break in between. During these visits, blood samples will be taken at different times after you take the tablet to measure the amount of medicine in your body. You'll likely need to fast (not eat) before taking the medicine for each dose. You'll also have checks like blood pressure and heart rate measurements. The total duration of your participation, including all visits and follow-ups, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a study like this might have some small potential benefits, such as contributing to medical knowledge and potentially receiving free health checks during your participation. However, the main benefit is for future patients, ensuring new medicines are safe and effective. Potential risks could include discomfort from blood draws, temporary side effects from the medication (even in healthy people, though these studies are carefully designed), or mild inconvenience due to clinic visits and fasting. You have the right to withdraw from the study at any time, for any reason, without it affecting your future 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 does 'bioequivalence' mean?

It means scientists are checking if a new version of a medicine acts the same way in your body as an existing, approved version – for example, if it gets into your bloodstream at the same speed and level.

Will I be taking a real medicine or a dummy pill?

You will be given both the new tofacitinib tablet and the existing Xeljanz® tablet at different times throughout the study. There are no dummy pills involved in this type of study.

Do I need to be ill to join this study?

No, quite the opposite! This study is specifically looking for healthy volunteers, meaning you should not have any significant medical conditions.

How long will I have to fast during the study?

You will likely be asked not to eat or drink anything (except water) for a certain number of hours before you take the study tablet. The study team will give you clear instructions on fasting times.

What happens to the information collected from me?

All information collected from you will be kept confidential and your privacy protected. It will be used to help understand how the new medicine works and will be anonymised for research purposes.