Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A bioequivalence study comparing Empagliflozin 25 mg film-coated tablets, VIANEX S.A., Greece versus Jardiance 25 mg film-coated tablets, Boehringer Ingelheim International GmbH, Germany, in healthy male and female volunteers under fasting conditions.

This study is looking at two different empagliflozin medicines. One is the original 'Jardiance' and the other is a new version made by VIANEX S.A. The main goal is to see if the new version of the medicine acts the same way in the body as the original one, particularly when taken on an empty stomach. This is called a 'bioequivalence' study. It involves healthy adult men and women, meaning people who don't have any specific health conditions that would affect the medicine's action. Studies like this are an important step in making sure new medicines are just as safe and effective as existing ones before they can be used more widely.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Vianex S.A.

Enrolment target

Start

18 Feb 2026

none - healthy volunteers

What is this study about?

This research study is focused on a medicine called empagliflozin. You might know it by its brand name, Jardiance. This medicine is primarily used to help people with type 2 diabetes manage their blood sugar, and it's also used for certain heart and kidney conditions. The study is comparing the original empagliflozin medicine (Jardiance) with a new, similar version being developed by another company.

The main aim is to check if these two versions of empagliflozin behave in the same way inside the body. This is called a 'bioequivalence' study. Imagine you have two identical keys from different manufacturers – they both need to open the same lock in the same way. Similarly, this study wants to confirm that the new empagliflozin medicine gets into the bloodstream at the same rate and to the same extent as the original one. This is crucial for ensuring that the new version will be just as effective and safe for patients.

These types of studies are a vital part of developing new medicines. If the new version is proven to be bioequivalent, it means it can be offered to patients as an alternative to the original. This can sometimes lead to more affordable options for medicines, making them more accessible to people who need them.

Key takeaways

This study compares two versions of the diabetes medicine Empagliflozin.
It aims to confirm a new version works just like the original one.
Only healthy adult men and women, aged 18+, can take part.
You'll take the medicine on an empty stomach and have regular checks.
Participation helps bring new, potentially more affordable medicines to people.
You can stop participating at any time.

Who may be eligible?

This study is looking for healthy adult men and women to take part. Being 'healthy' means you don't have any major medical conditions that could affect how your body handles the medicine being tested.

You need to be at least 18 years old to participate. There isn't an upper age limit mentioned, but generally, participants are in a good state of health.

Because this is a study looking at how a medicine works in a healthy body, people with existing health problems or who are on other medications might not be suitable. This helps to make sure that any effects seen are purely due to the study medicine.

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 major medical conditions?
Are you able to attend study visits, including fasting periods?
Are you not currently taking other medications that might interfere with the study?
Are you comfortable with blood tests and medical monitoring?

Answer every question to see your result.

What does participation involve?

This study involves a few visits to a research clinic, especially during the times you'll be taking the study medicine. You'll likely stay at the clinic for a short period after taking the medicine so that doctors and nurses can monitor you closely and take blood samples. These samples help them track how the medicine moves through your body.

You'll be given the empagliflozin medicine (either the original or the new version) as a tablet. The study specifies that it will be taken on an empty stomach. There will also be follow-up appointments and checks to make sure you're feeling well and to gather all necessary information. The exact number of visits and the total length of time you'll be involved in the study will be explained in detail by the research team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For healthy volunteers, a direct medical benefit isn't usually the primary aim, but you might gain a better understanding of how clinical research works and contribute to medical science. As with any medicine, there's a chance of experiencing side effects, although empagliflozin is generally well-tolerated. The research team will carefully monitor you for any effects and explain all known risks. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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, and sometimes for heart and kidney conditions.

Why are you comparing these two medicines?

We want to see if a new version of empagliflozin works exactly the same way in the body as the original 'Jardiance' medicine.

Do I need to have diabetes to join?

No, this study is looking for healthy volunteers, meaning people without diabetes or other major health conditions.

What does 'fasting conditions' mean?

It means you'll usually need to avoid eating or drinking (other than water) for a certain number of hours before taking the study medicine.

Will I get paid for taking part?

Some studies offer payment for your time and travel, but this would be confirmed by the research team directly.