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 Fed Conditions

This clinical trial, called a bioequivalence study, aimed to see if a new tablet containing the medicine Tofacitinib is absorbed and works in the body in the same way as the already approved medicine, Xeljanz®. Tofacitinib is often used to treat conditions like arthritis. This study didn't involve anyone with a medical condition; instead, it focused on healthy volunteers. Participants took the medication with food, and researchers measured how much medicine got into their bloodstream over time. The main goal was to confirm that the new tablet is just as effective and safe as the original, meaning patients could potentially have another option for their treatment.

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 a branded medicine that works well, and now a new company wants to make their own version of that medicine. Before they can offer it to patients, they need to prove it's just as good as the original. That's exactly what this study is about. It's comparing a new tablet containing a medicine called Tofacitinib with the original branded tablet, Xeljanz®.

The main aim was to see if, once swallowed, the new tablet delivered the same amount of medicine into the body and at the same speed as the original Xeljanz®. This is important because it ensures that the new version will have the same effects and be as safe as the medicine already on the market. They specifically looked at how the medicine behaved when taken with food, as this can sometimes affect how medicines are absorbed.

Studies like this are very standard and are a key step before new versions of medicines can become available. They help ensure that patients receive consistent, effective treatment regardless of which company makes their medication. It's all about making sure medicines work as expected.

Key takeaways

This study compared a new Tofacitinib tablet to the original Xeljanz®.
The goal was to confirm the new tablet works the same way in the body.
Healthy volunteers aged 18 and over, of any sex, were included.
Participants took the medicine with food.
This type of study ensures new medications are reliable and effective.
It's a foundational step in bringing new drug options to patients.

Who may be eligible?

To join this study, suitable participants were healthy individuals aged 18 or older. There was no upper age limit mentioned, meaning older adults could also take part if they met all other health criteria.

Both men and women were able to participate in this research. The study was not looking for people with specific medical conditions; instead, it needed participants who were generally healthy to accurately test how the medication was absorbed in a typical body.

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 major medical conditions?
Are you able to follow specific study instructions?
Are you comfortable with regular blood tests?

Answer every question to see your result.

What does participation involve?

If you were to take part in a study like this, you would first go through a screening process. This would involve health checks, tests, and a review of your medical history to make sure you are healthy enough to join. If you qualify, you would visit the study clinic several times. During these visits, you would receive the study medication (either the new tablet or Xeljanz®) with food. After taking the medicine, blood samples would be collected regularly over a certain period to measure how much medicine is in your system. This helps researchers understand how the body processes the medication. You would be carefully monitored throughout your time at the clinic. The total duration of participation, including all visits and follow-up, is typically several weeks, with specific clinic stays for blood sampling.

Potential risks and benefits

Taking part in any study has potential aspects to consider. For this type of study, a potential benefit is contributing to medical science, which helps make new medicine options available. There are usually no direct health benefits for participants in bioequivalence studies as they are healthy volunteers. Potential risks are generally low, but could include minor discomfort from blood draws, or potential side effects from the study medication, though healthy volunteers are carefully monitored for any reactions. You would be fully informed of all known risks before joining, and you always 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 does 'bioequivalence' mean?

It means checking if two medicines have the same effect in the body, specifically if they are absorbed and act the same way.

Why were healthy people part of this study?

Using healthy people allows researchers to see how the medicine acts in the body without other health conditions affecting the results, making the comparison accurate.

What is Tofacitinib used for?

Tofacitinib is a medicine often prescribed for conditions like rheumatoid arthritis or ulcerative colitis, helping to reduce inflammation.

Was this a study to find a cure for a disease?

No, this study wasn't looking for a cure. It was focused on making sure a new version of an existing medicine works just as well as the original.

What does 'fed conditions' mean?

It simply means that participants took the medicine after eating a meal, to see how food might affect how the medicine is absorbed.