Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A single-dose, open-label, randomized, two-period, two-sequence, crossover pivotal bioequivalence study on two amoxicillin-clavulanic acid film-coated tablet formulations in healthy volunteers under fed conditions.

This study is investigating a new way of making a common antibiotic, amoxicillin-clavulanic acid, which treats various infections. We want to check if this new tablet, when taken by healthy adults with food, performs just as well as the existing version. This is important to make sure patients get the same effective treatment. Participants will take both the new and old tablets at different times. The main goal is to confirm that the body absorbs and uses the active ingredients from both tablets in the same way. This helps ensure new medicines are safe and effective before they are widely used.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Tarchominskie Zaklady Farmaceutyczne Polfa S.A.

Enrolment target

Start

15 Jul 2025

infections

What is this study about?

This study is about an antibiotic medicine called amoxicillin-clavulanic acid, which is often prescribed to treat different types of infections. Think of it like a new recipe for a familiar cake – we want to make sure the new version tastes just as good, or in this case, works just as well.

The main goal is to compare a new tablet formulation of this antibiotic with the original one. We want to see if your body absorbs and uses the medicine from the new tablet in the exact same way as it does from the older, established one. This is called 'bioequivalence' – it's a scientific way of saying they are equally effective. This study will specifically look at how the medicine works when taken with food.

Studies like this are a really important step before a new medicine can be made widely available. They help ensure that any new version of a drug provides the same benefits and safety as the original. By doing this comparison, we can be confident that patients will receive the correct amount of medicine to fight their infections, no matter which version of the tablet they are given.

Key takeaways

Compares a new antibiotic tablet to an existing one.
Aims to ensure both tablets work the same way in the body.
Looks at how the medicine is absorbed when taken with food.
Involves healthy adults (age 18 and over, all genders).
Participation includes taking medication, blood tests, and clinic visits.
Helps make sure new medicines are safe and effective for patients.

Who may be eligible?

This study is looking for healthy adult volunteers to take part. This means you should be generally well and not have any serious ongoing health problems.

To be eligible, you need to be at least 18 years old or older. There is no upper age limit, meaning people of all adult ages can potentially participate.

Both men and women are welcome to join this study. The researchers want to get a good understanding of how the medicine works in different healthy individuals.

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 comfortable with taking medication and having blood tests?
Can you commit to attending multiple clinic visits?
Are you able to follow specific instructions about food and medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given both the new and the existing versions of the antibiotic tablets at different times. This means you will spend time at the study clinic for each 'period' of the study. During these visits, blood samples will be taken regularly to see how your body is absorbing the medicine. You will also be asked to eat a standard meal with the medication. The study involves a few visits over a period of time, with a washout period (a time when you don't take any study medication) in between. The total duration of your involvement, from your first visit to your last, will be explained fully by the study team.

Potential risks and benefits

Participating in research studies always carries potential benefits and risks. The main benefit of taking part in this study is contributing to medical knowledge and helping to ensure new medicines are safe and effective for others. You will receive close medical supervision during the study. Potential risks are generally mild and similar to those you might experience from a standard blood test, such as bruising or discomfort. There's also the chance of mild side effects from the antibiotic itself. 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.

—
Unverified
Czechia

Common questions

What is amoxicillin-clavulanic acid?

It's a common antibiotic medicine used to treat various bacterial infections.

Why are you doing this study?

We want to check if a new version of the antibiotic tablet works exactly the same way as the original, especially when taken with food.

Will I get paid for taking part?

The study team will be able to tell you if there is any payment for your time and inconvenience.

Do I have to take both tablets?

Yes, to compare them properly, you will take both the new and original tablets at different times during the study.

What if I get sick during the study?

You'll be closely monitored, and the study team will provide guidance. You can also withdraw at any time.