Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

The pivotal bioequivalence study comparing the test product to the reference product, which belongs to the group of medicines used in treatment of type 2 diabetes mellitus in adults and children aged 10 years and above, and heart failure and chronic kidney disease in adults patiens.

This research is looking at a new version of a medicine that is already approved and used to treat type 2 diabetes in adults and children aged 10 and over. It's also used for adults with heart failure and long-term kidney disease. The study aims to confirm that this new version works just like the original medicine inside the body. This type of study is called a 'bioequivalence study'. It's an important step to ensure that the new medicine is just as safe and effective as the one currently available. We will be inviting healthy adult volunteers to take part in this initial phase of testing.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Adamed Pharma S.A.

Enrolment target

Start

19 Aug 2025

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

What is this study about?

This study is all about making sure that a new version of an important medicine works exactly the same way as the original. Imagine you have a branded breakfast cereal you love, and a supermarket brings out their own version. This study is like making sure the supermarket's cereal has the same ingredients, taste, and nutritional benefits as the brand-name one.

The medicine we're looking at is used for some serious health conditions: type 2 diabetes (a condition where your body can't control its blood sugar properly), heart failure (when your heart struggles to pump enough blood), and chronic kidney disease (when your kidneys don't work as well as they should).

By checking if the new version of the medicine acts the same way in healthy people, we can be confident it will also work effectively and safely for patients who need it. This is a crucial step before the new medicine can be made available more widely. It helps ensure that patients will get the same reliable treatment they expect.

Key takeaways

Tests a new version of an existing diabetes, heart, and kidney medicine.
Aims to prove the new version works just like the original one.
Involves healthy adult volunteers, 18 years and older.
Requires careful monitoring, including blood tests.
Participation helps bring new, reliable medicines to patients.

Who may be eligible?

To join this study, we are looking for healthy adults. This means you should generally be in good health and not have any serious medical conditions that could affect how the medicine works or put you at risk.

We welcome both men and women to take part. You must be at least 18 years old to be considered for this study. There is no upper age limit, meaning as long as you meet the health criteria, your age won't stop you from participating.

Since this is a study involving healthy people to check how the medicine behaves, people with the actual conditions that the medicine treats (like type 2 diabetes, heart failure, or kidney disease) are generally not suitable for this particular 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.

Are you 18 years old or older?
Are you generally in good health?
Are you able to attend clinic visits as required?
Are you willing to provide blood samples?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given a dose of the medicine. We'll then closely monitor your body's response, likely taking blood samples at specific times to see how the medicine is absorbed and processed. You might need to stay at a special research clinic for a period, with visits before and after to check your health. The total duration of your involvement could range from a few days to a few weeks, depending on the exact study plan, including follow-up checks. All procedures will be clearly explained before you agree to participate.

Potential risks and benefits

Taking part in any study has potential pros and cons. A potential benefit is contributing to medical science and helping to make new medications available to patients. You'll also receive careful health monitoring during the study period. Potential risks might include minor discomfort from blood draws, or very rarely, unexpected side effects from the medication, even though it's a known medicine. You are always free 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
Czechia

Common questions

What kind of medicine are you testing?

We are testing a new version of an existing medicine used for type 2 diabetes, heart failure, and chronic kidney disease.

Who can join this study?

Healthy adult volunteers aged 18 and over are eligible to participate.

Will I have to stay overnight somewhere?

It's possible you might need to stay at a research clinic for a period, but all details will be explained to you before you commit.

Is this medicine new to the market?

No, the original medicine is already available. This study is testing if a new version works exactly the same way.

Will I get paid for taking part?

Studies often offer compensation for your time and travel. This will be discussed with you before you agree to participate.