Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence Study of Empagliflozin

This study is a bioequivalence (pronounced bye-oh-ee-KWIV-uh-lence) trial, which means it compares how two different versions of the same medicine, empagliflozin, are absorbed and used by the body. Empagliflozin is a medicine for type 2 diabetes. This research is done to make sure that a new version of the medicine works just as effectively as the original. Healthy adults over the age of 18 are invited to take part. It's an early-stage study, meaning it helps scientists understand the basic way the medicine acts in people, rather than testing it for a specific illness.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Tarchominskie Zaklady Farmaceutyczne Polfa S.A.

Enrolment target

Start

11 Mar 2026

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

What is this study about?

Imagine you have a key, and you want to make sure a new copy of that key works exactly the same as the original. That's a bit like what this study is doing, but with medicine! The medicine in question is called empagliflozin, which is used to treat type 2 diabetes. Researchers are comparing two different versions of this medicine to see if they are absorbed into the body and act in the same way. This is called a 'bioequivalence' study.

The main goal of this type of study is to ensure that a newer version of a medication is just as good, safe, and effective as an older, established version. It's a really important step before a new medicine can be made available to more people. This study helps answer questions like, 'Does the new version reach the bloodstream at the same speed and in the same amount as the original?' If the answer is yes, it means they are essentially the same for your body.

This particular study is only looking at how the medicine behaves in healthy volunteers, not in people who have diabetes. This allows researchers to focus purely on how the body handles the medicine without other health conditions making it more complicated. It's an early stage of research, usually done before a medicine is tested in people with the condition it's meant to treat.

Key takeaways

This study compares how two versions of a diabetes medicine, empagliflozin, work in the body.
It's for healthy adults aged 18 and over, both men and women.
The aim is to make sure new versions of the medicine are absorbed just like the original.
You would receive the study medicine and have blood taken regularly to see how it moves through your system.
Your health would be monitored closely by medical professionals throughout your participation.
Participation helps advance medical science and ensures medicines are safe and effective.

Who may be eligible?

This study is looking for healthy adults to take part. This means you should generally be in good health and not have any serious ongoing medical conditions. It’s important that your body is working as it typically does, so the researchers can get a clear picture of how the medicine acts without other health issues getting in the way.

To be considered, you must be 18 years old or older. There is no upper age limit, meaning that older adults who are generally healthy can also take part. Both men and women are welcome to participate in this 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 healthy with no serious ongoing medical conditions?
Are you able to commit to several clinic visits?
Are you comfortable having regular blood samples taken?
Are you okay with potentially being given a medicine that treats diabetes, even though you don't have it?

Answer every question to see your result.

What does participation involve?

While the exact details aren't fully listed, a bioequivalence study typically involves several visits to a clinic over a period of time. You would likely be given doses of the empagliflozin medicine, and then blood samples would be taken regularly over many hours to measure how the medicine is absorbed and cleared from your body. You might also have other check-ups like blood pressure readings and general health assessments. There will be clear instructions on what you can or cannot eat, drink, or do (like exercise) around the time you take the medicine. You would be closely monitored by medical staff throughout the study dates. The total duration can vary, often lasting a few weeks with several clinic visits, some of which might be long days.

Potential risks and benefits

Participating in any study has potential aspects to consider. For this study, potential benefits might include contributing to medical science and helping to ensure new medicines are safe and effective for others. You would also receive health checks during your participation. Potential risks could include side effects from the study medication, though healthy volunteers are carefully chosen, and the drug is already known. There's also the time commitment involved. You have the right 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 is empagliflozin?

Empagliflozin is a medicine typically used to help manage type 2 diabetes, but this study is looking at how it works in healthy people.

Why are you studying healthy people?

Studying healthy people helps researchers understand exactly how the medicine is absorbed and processed by the body without other health conditions making it more complicated. It's an important first step.

What does 'bioequivalence' mean?

It means comparing two versions of the same medicine to see if they act in the body in the same way, specifically how they are absorbed and reach your bloodstream.

Will I get paid to take part?

Many clinical trials offer some payment or reimbursement for your time and travel, but you would need to confirm this with the study team.

Is this medicine new?

Empagliflozin is an existing medicine. This study is comparing a version of it, possibly a new generic version or formulation, to ensure it works the same as the original.