AuthorisedHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A study in healthy people to compare two tablet formulations of pramipexole

This study is a test of two different tablet forms of a medicine called pramipexole. It's designed for healthy volunteers and aims to check if the new tablet works in the same way as an existing one. This type of research is an important early step in developing medicines, helping scientists understand how the drug is absorbed and used by the body. The goal is to make sure any new version of a medicine is just as effective and safe as the original. This helps ensure that when doctors prescribe medicines, they know they will work as expected for patients.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

22 May 2026

Healthy volunteer trial

What is this study about?

This research study is about a medicine called pramipexole. Doctors sometimes prescribe pramipexole for conditions like Parkinson's disease, which affects movement, or restless legs syndrome, which causes uncomfortable sensations in the legs. For these medicines to be used, they first need to be thoroughly tested.

In this particular study, researchers are comparing two slightly different tablet forms of pramipexole. Think of it like comparing two brands of a familiar product – researchers want to see if both brands do the same job in the same way. This is a very common and important step when new versions of existing medicines are developed. They need to check that the new tablet delivers the medicine to the body just as effectively as the original.

This type of study is specifically designed for healthy people, not those with an illness. It's called a 'bioequivalence' study. This means they are checking if the two forms of the medicine are 'bioequivalent' – that is, if they release the active ingredient into your body and absorb it at the same rate and to the same extent. This helps ensure that if a new tablet is introduced, it will have the same effect as the one doctors are already familiar with, giving patients confidence in its effectiveness.

Key takeaways

Compares two pramipexole tablet versions.
For healthy adults only.
A 'Phase I' study – an early stage of drug development.
Aims to check if the tablets are equally absorbed by the body.
Helps ensure future medicines are safe and effective.
Participation involves clinic visits and blood tests.

Who may be eligible?

This study is looking for healthy adults to take part. To be considered, you need to be at least 18 years old. There's no upper age limit, so older adults can also participate if they are otherwise healthy.

Both men and women are welcome to join this study. The most important thing is that you are generally in good health, as confirmed by the study doctors after some checks. The aim is to understand how the medicine works in typical healthy bodies, not bodies that are already dealing with other health challenges, as that could change the results.

Quick self-check

Are you 18 years old or older?
Are you generally in good health?
Are you male or female?
Are you able to attend several clinic visits?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would receive doses of the pramipexole tablets being tested. You would have several visits to the study clinic, where doctors and nurses would perform health checks and take blood samples. These samples help them see how your body absorbs and processes the medicine. The exact number of visits, tests, and the total time you would be involved would be fully explained by the study team before you agree to take part. You would also have follow-up checks after you stop taking the medicine to ensure you are well.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A small benefit might be that you receive thorough health checks from medical professionals. The main benefit, though, is contributing to medical research and helping to make sure new medicines are safe and work well for future patients. Potential risks could include side effects from the medication, which would be fully explained to you before you start. There's also the discomfort of blood tests. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Germany

Common questions

What is pramipexole normally used for?

Pramipexole is a medicine that doctors prescribe for conditions like Parkinson's disease or restless legs syndrome.

Why are you testing two different tablets of the same medicine?

Researchers are comparing two tablet forms to make sure a new version works exactly the same way as an existing one in the body.

Do I need to have a medical condition to join?

No, this study is specifically looking for healthy volunteers, not people with a medical condition.

Will I know which tablet I am taking?

The study team will explain how the tablets are given. Sometimes, participants don't know which version they're taking until after the study is over, to keep the results fair.

Will I get paid for taking part?

It's common for healthy volunteer studies to offer some payment for your time and inconvenience, but you should ask the study team directly about this.