Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

The pivotal bioequivalence study comparing the test product to the reference product, which belong to the group of medicines used in the treatment of type 2 diabetes mellitus when the condition cannot be adequately controlled by diet and exercise alone.

This study is looking at a new version of a medicine used to treat type 2 diabetes. If you have type 2 diabetes and diet and exercise alone aren't enough to manage your condition, this type of medicine might be prescribed. The main goal of this particular study is to check if this new version works exactly the same in your body as the original, already approved medicine. This is called a 'bioequivalence' study. It helps ensure that patients will get the same consistent effect from the new medicine as they would from the existing one. We are looking for healthy adults to take part.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Adamed Pharma S.A.

Enrolment target

Start

08 Sep 2025

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

What is this study about?

Imagine you have type 2 diabetes, a condition where your body struggles to use sugar properly, leading to high blood sugar levels. Often, doctors advise changes to your diet and more exercise to help manage this. However, sometimes these changes aren't quite enough, and that's when medicines are needed to help bring your blood sugar down.

This study is focusing on a new version of a medicine that falls into this group – medicines used for type 2 diabetes when diet and exercise aren't enough. It's a very early stage of testing, often called a 'Phase I' study. In simple terms, it's like comparing two popular brands of a similar product to make sure they both do the exact same job when you use them.

The main purpose is to see if the new medicine behaves in the body in the same way as an already approved and well-known diabetes medicine. This process is called 'bioequivalence.' It's a standard and important step to ensure that if this new medicine becomes available, it will be just as effective and safe as the one doctors already prescribe.

Key takeaways

This study tests a new version of an existing type 2 diabetes medicine.
It's about making sure the new version works the same as the original.
Healthy adults (18+) are needed to take part.
It's an early-stage study to gather basic information.
Your participation helps to ensure consistent medicine quality.

Who may be eligible?

This study is looking for healthy adult volunteers. You or your doctor won't need to check if you have a specific illness to join, as the focus is on how the new medicine works in a healthy body.

To be eligible, you need to be at least 18 years old. There's no upper age limit, meaning adults of any age can take part.

Both men and women are welcome to participate in this study. The researchers aim to have a diverse group of participants.

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 a healthy adult?
Are you able to attend clinic visits as required?
Are you comfortable with blood tests?

Answer every question to see your result.

What does participation involve?

Details about what taking part involves would be explained thoroughly by the study team. Usually, bioequivalence studies involve several visits to a clinic over a short period. You would likely be given doses of the study medicine, and then have blood samples taken regularly to see how the medicine is absorbed and leaves your body. You might also have other health checks, like blood pressure readings. The study will involve a specific schedule of these visits and assessments, so you would know exactly what to expect and for how long you'd be involved.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit could be contributing to important medical research that helps bring new, equivalent medicines to patients. As this is a study in healthy people, there might not be direct health benefits for you personally. Potential risks might include side effects from the study medicine, discomfort from blood draws, or the time commitment. You will be given all the information about possible risks and side effects, and you are always free to leave 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
Czechia

Common questions

What is type 2 diabetes?

Type 2 diabetes is a common condition where your body doesn't produce enough insulin, or the insulin it produces doesn't work properly. This means your blood sugar levels can get too high.

What does 'bioequivalence study' mean?

It means the study is comparing a new version of a medicine to an existing one to make sure they act the same way in the body. It's like checking if a generic brand works just as well as the original.

Do I need to have type 2 diabetes to join?

No, this particular study is looking for healthy volunteers, not people with type 2 diabetes. The purpose is to see how the medicine functions in a healthy system.

What will I have to do if I join?

You would likely visit a clinic multiple times, receive the study medicine, and have blood samples taken at different times to see how your body handles it.

Will I get paid for taking part?

Many healthy volunteer studies offer compensation for your time and travel, but specific details would be discussed with you by the study team.