Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence study 2 to compare pharmacokinetics of Parkinson´s disease drugs in healthy volunteers

This study is a bioequivalence trial, which means we're comparing how different versions of a Parkinson's disease medicine are absorbed and used by the body. We're looking for healthy adults, aged 18 and older, to take part. This type of research is really important because it helps ensure that new versions of medicines are just as effective and safe as the original ones. Even though the study is about Parkinson's medicine, participants don't need to have Parkinson's disease, as we are studying how the body generally processes these drugs. By understanding this, we can make sure people with Parkinson's receive reliable and consistent treatment in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Orion Corporation

Enrolment target

Start

27 Mar 2026

Parkinson desease

What is this study about?

Imagine you have two different brands of the same common painkiller. This study is similar to that, but for medicines used to treat Parkinson's disease. We want to make sure that different versions of these medicines are handled by your body in exactly the same way. This means checking if they get into your bloodstream at the same speed and in the same amounts. It’s like ensuring two different keys open the same lock equally well.

Why is this important? When a medicine is first developed, it might be made by one company. Later, other companies might want to make their own versions, often called 'generics'. For these new versions to be approved for use, we need to prove they work just as effectively and safely as the original. This study is a crucial step in that process, helping to make sure that patients with Parkinson's disease get consistent and reliable treatment, no matter which version of the medicine they are prescribed.

Even though the medicines are for Parkinson's, we need healthy volunteers for this study. This helps us see how the medicine works in a body that isn't already affected by the disease. It provides a clear picture of how the drug is absorbed, distributed, and removed, without the complications of an existing health condition.

Key takeaways

This study compares different versions of Parkinson’s disease medicines.
It needs healthy volunteers, 18 years and older.
The goal is to ensure new medicines work reliably.
Participation involves taking medicine and having blood tests.
Your well-being will be monitored closely.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older. There is no upper age limit, so adults of all ages, as long as they are 18 or over, may be able to take part.

We are looking for both men and women to participate. This helps us understand how the medicines work across different people. The main requirement is that you are healthy, as this helps us get the clearest information about how the medicines behave in the body.

Specific health checks will be done by the study team to make sure it's safe for you to take part. They will look at things like your general health, any medications you currently take, and your medical history. This is to ensure your safety throughout 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.

Am I 18 years old or older?
Am I generally in good health?
Am I able to visit the study clinic as required?
Am I comfortable with giving blood samples?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be giving a small amount of your time to help medical research. We don't have all the details about exact visits, but typically, studies like this involve a screening visit to check if you're suitable. If you pass, you would then have a few study visits where you'll receive the medication. You might need to stay at a clinic for a short period, possibly overnight, to have blood samples taken at different times after taking the medicine.

These blood tests help us measure how much of the medicine is in your body and for how long. You'll be closely monitored by medical staff throughout these visits. There will also be follow-up calls or visits to check on your well-being. The total duration of your involvement could range from a few days to a few weeks, including screening and follow-up, depending on the specific study design.

Potential risks and benefits

Taking part in a study like this can help advance medical understanding and contribute to better treatments for people with Parkinson's disease. You might also receive reimbursement for your time and travel. However, like all medicines, the study drugs could have side effects, even in healthy people. These are usually mild and temporary, but the study team will explain all known or potential risks to you. You are free to ask questions at any time and can decide to leave the study at any point without giving a reason.

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

Do I need to have Parkinson's disease to join this study?

No, you do not. This study is looking for healthy volunteers only.

What will I have to do during the study?

You'll likely have screening checks, take the study medicine, and give blood samples at specific times to see how your body handles it.

Will I be paid for taking part?

Many studies offer some reimbursement for your time, travel, and inconvenience. You should ask the study team about this.

How long will I be involved in the study?

The full details are not here, but these kinds of studies typically involve a few visits over days or weeks, including follow-up.

Can I stop participating if I change my mind?

Yes, absolutely. Your participation is completely voluntary, and you can withdraw at any time without needing to give a reason.