Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence of Amoxicillin and Clavulanic Acid 875 mg/125 mg Film-Coated Tablets in Healthy Participants Under Fed Conditions.

We're looking for healthy people, aged 18 and over, to take part in a study testing a common antibiotic. This antibiotic is called amoxicillin and clavulanic acid, and it's used for many infections. The study wants to see if a newer version of the tablet works in the exact same way as an older, established version in the body, especially when taken with food. This kind of research is called a bioequivalence study. It’s an important step to ensure that any new medicine is just as effective and safe as the original. By comparing them, we can be confident that patients will get the same reliable treatment, regardless of which version of the tablet they receive.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Bial Portela & Ca S.A.

Enrolment target

Start

11 Jul 2024

No medical condition.

What is this study about?

Imagine you have a headache and you take a painkiller. You trust that it will work consistently every time. This study is similar, but for an antibiotic called amoxicillin and clavulanic acid. This medicine is often prescribed to treat various bacterial infections.

When a new version of an existing medicine is made, even if it has the same ingredients, it needs to be thoroughly checked. This study aims to see if two different tablets containing amoxicillin and clavulanic acid behave in exactly the same way in the body. This is called a 'bioequivalence' study. It means we want to confirm that the new tablet releases the medicine into your bloodstream at the same speed and to the same extent as an older, trusted tablet, especially when you've just eaten.

Why does this matter? It's all about making sure you receive reliable treatment. If a new version of a medicine is shown to be 'bioequivalent', it means healthcare professionals can prescribe it with confidence, knowing it will work just as effectively as the original. This helps ensure that patients, like you, always get high-quality, dependable medication.

Key takeaways

Tests a common antibiotic called amoxicillin and clavulanic acid.
Compares two versions of the tablet to ensure they work the same.
Only for healthy volunteers, aged 18 and above.
Aims to confirm new medicines are as reliable as existing ones.
You'll be fully informed about what's involved and any potential side effects.

Who may be eligible?

To be considered for this study, you need to be a healthy adult, at least 18 years old. We're looking for both men and women.

Since this study is about checking how a medicine works in healthy people, you shouldn't have any ongoing medical conditions. This helps us get clear results without other health issues affecting how the medicine behaves in your body.

More detailed checks will happen if you express interest, including reviewing your medical history and a general health check to make sure participating is safe for you.

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 and don't have any ongoing medical conditions?
Are you comfortable having blood samples taken?
Are you able to follow study instructions carefully?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the antibiotic tablets to take. The study will pay close attention to how your body handles the medicine, specifically by taking blood samples at set times after you've taken the tablet, usually after you've eaten a meal. This helps researchers measure the levels of the medicine in your bloodstream. You would likely need to visit a clinic for these assessments over a short period. The full duration of your involvement, including all visits and follow-ups, would be explained in detail before you agree to participate.

Potential risks and benefits

The main benefit of participating is contributing to medical knowledge, which helps ensure that new versions of common medicines are safe and work just as well as existing ones for future patients. Like any medicine, amoxicillin and clavulanic acid can have side effects, which you would be fully informed about before deciding to take part. These are generally well-known and often mild. There's also the discomfort of blood tests. Remember, 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
Portugal

Common questions

What is amoxicillin and clavulanic acid?

It's a common antibiotic medicine used to treat bacterial infections, like chest infections or ear infections.

What does 'bioequivalence' mean?

It means the study is checking if a new version of a medicine works in exactly the same way as an older, established version in your body.

Do I need to be ill to join this study?

No, quite the opposite! This study needs healthy volunteers so researchers can clearly see how the medicine works without other health problems getting in the way.

Will I get paid for taking part?

Often, studies like this offer some payment for your time and inconvenience. The study team will explain this to you.

Will my regular doctor know I'm in the study?

That's usually up to you. You can discuss whether you want your doctor informed with the study team.