Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

An open label, randomized, crossover, two-period, two-sequence, single dose study to assess the relative bioavailability of Rotigotine 4.5 mg (2 mg/24 hrs) transdermal patch (Test Product) compared to Neupro® 2 mg/24 h Transdermal Patch (Reference product) in 48 healthy adult volunteers under fasting conditions.

This study is a research trial looking at a new version of a skin patch that delivers medicine, specifically a 4.5 mg Rotigotine patch. We want to see how well it works compared to the existing Neupro® 2 mg/24 hour patch. To do this, we'll ask 48 healthy adults to wear both types of patches at different times. We'll then measure how much of the medicine gets into their bodies from each patch. This type of study, called a "bioequivalence study," is important because it helps ensure that a new medicine or a new way of giving a medicine works just as effectively and safely as an established one. It's a first step in testing new medical treatments.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Eva Pharma For Pharmaceuticals And Medical Appliances SAE

Enrolment target

Start

06 Sep 2024

Not applicable (submitted trial is a bioavailability study in healthy subjects).

What is this study about?

Imagine you have a new way to get a medication into your body, like a new type of skin patch. Before doctors can prescribe it widely, they need to be sure it works just as well as existing options. This study aims to do exactly that for a patch that delivers a medicine called Rotigotine.

We're comparing a new Rotigotine 4.5 mg patch to an already approved patch called Neupro® 2 mg/24h. We want to find out if the new patch releases the medicine into the body in a similar way and at similar levels. This is called 'bioequivalence' – essentially, does the new patch do the same job as the old one when it comes to getting the medicine into your system?

This is a very early-stage study, meaning it's one of the first steps in testing a new treatment. We're asking healthy volunteers to take part, not people with specific illnesses. This helps us understand how the patch performs in a healthy body before it's tested in people who might benefit from the medicine it delivers. It's an important part of making sure new medicines are safe and effective for everyone.

Key takeaways

The study compares a new medicine patch to an existing one.
It's for healthy adults aged 18 and over.
The main goal is to see how much medicine gets into the body from each patch.
Participation involves wearing patches and having blood tests.
It's an important early step in developing new medicines.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 years or older. This study is open to both men and women.

Since this study isn't looking at a specific health condition, you generally need to be in good overall health. The researchers will carry out checks to make sure you're healthy enough to take part and that the study is suitable for you. While we can't list every single requirement here, the main idea is to ensure that participants are in good health.

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 in good health?
Are you available for multiple clinic visits?
Are you comfortable having blood samples taken?
Are you able to follow specific instructions, like fasting before tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be involved in a "crossover" study, which means you'll try each type of patch at different times. You will wear the test patch (the new one) at one point, and the reference patch (the existing one) at another. There will be some time between wearing each patch.

During various visits to the study clinic, likely over several days, blood samples will be taken regularly to measure how much of the medicine has entered your body. You'll need to follow specific instructions, including fasting (not eating) before certain tests. The total duration of your involvement, including all visits and follow-up, will be explained in full detail by the study team.

Potential risks and benefits

Potential benefits of participating include contributing to medical science and helping to develop new treatments that could one day help many people. You might also receive free medical checks during the study. Potential risks could include mild side effects from the patch (like skin irritation), discomfort from blood tests, or unforeseen reactions to the medicine. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care, and your decision will always be respected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Czechia

Common questions

What is Rotigotine?

Rotigotine is a medicine often used to treat conditions like Parkinson's disease, but this particular study is just about how it gets into the body from a patch, not its effects on those conditions.

What does 'bioequivalence' mean?

It means we're checking if a new version of a medicine (like a new patch) delivers the same amount of medicine to your body, at a similar speed, as an existing, approved version.

Will I get paid to participate?

Information about payment for your time and travel in research studies is usually provided by the study team. You should ask them if this is important to you.

Will I know which patch I am wearing?

Yes, this is an "open-label" study, which means both you and the study team will know which patch (the new one or the existing one) you are wearing at each time.

Is this study safe for healthy people?

All studies go through strict checks by ethics committees and regulators to ensure participant safety. The study team will explain all known risks to you before you decide to take part.