Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence of Amoxicillin and Clavulanic Acid 500 mg/125 mg Film-Coated Tablets in Healthy Participants Under Fed Conditions.

This research study is about comparing different versions of a widely used antibiotic called Amoxicillin and Clavulanic Acid (500 mg/125 mg tablets). Doctors use this antibiotic to treat various infections. The main goal of this particular study is to see if a new version of the tablet is absorbed into the body in the same way as an existing, approved version. This is important to ensure that patients get the same amount of medicine, and therefore the same benefits, regardless of which version of the tablet they take. We are looking for healthy adults to take part, and all participants will have eaten a meal before taking the medication.

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 two different brands of a painkiller. You'd want to be sure that both brands work equally well, right? This study is very similar, but it's for a common antibiotic called Amoxicillin and Clavulanic Acid pills. This antibiotic is really important for treating many types of infections. The study is checking if a new version of these antibiotic tablets works in exactly the same way as a version that is already available and known to be safe and effective.

To figure this out, researchers give the new antibiotic to healthy volunteers after they've had a meal. They then measure how much of the medicine gets into the volunteers' blood and how quickly. This process is called a 'bioequivalence' study. It helps scientists confirm that the new and old versions of the pill deliver the same amount of medication to your body over time.

Why does this matter? Well, it means that if a new version of the medicine is approved, doctors can be confident that it will treat infections just as effectively as the original. This is a standard and important step in making sure new medications are safe and do what they're supposed to do for patients.

Key takeaways

Tests if a new antibiotic tablet is absorbed the same way as an existing one.
For healthy adults aged 18 and older.
Involves taking the antibiotic after eating.
Requires blood samples to measure medicine levels.
Helps ensure new medicines are safe and effective for future patients.
You can leave the study at any time.

Who may be eligible?

This study is looking for healthy adults. You don't need to have any particular medical condition to take part. In fact, they specifically want people who are generally well, as this helps them see how the medicine works in a healthy body.

You must be at least 18 years old to join this study. There is no upper age limit, meaning people of all adult ages can be considered. Both men and women are welcome to participate. The study team will check your health carefully to make sure it's safe for you to take part.

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 ongoing medical conditions?
Are you able to follow instructions from the study team?
Are you available for multiple study visits, including extended stays at a clinic?

Answer every question to see your result.

What does participation involve?

If you join the study, you will be given doses of the Amoxicillin and Clavulanic Acid tablets after you have eaten a meal. You will be asked to stay at the study centre for a period, where nurses will regularly take blood samples to measure how much of the medicine is in your body. This will happen over a few 'sessions' or visits, usually separated by a break. Before you start, you'll have a health check-up, and you'll have a final check-up at the end to make sure you're well. The total time you're involved in the study, from your first screening appointment to your last follow-up, could be several weeks, but the time spent actually taking medication and having blood tests will be concentrated into specific visits.

Potential risks and benefits

Taking part in this study won't directly improve your health, as it's designed for healthy people. However, you'll be contributing to scientific knowledge that helps ensure new medicines are safe and effective for others. Like all medications, Amoxicillin and Clavulanic Acid can have side effects, such as tummy upset or skin rashes, which you'll be monitored for. There might also be some discomfort from blood tests. 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 medication used to treat bacterial infections.

Why is this study only for healthy people?

Measuring how the medicine works in healthy people helps researchers clearly see its basic effects without other health problems affecting the results.

Will I get sick from taking the antibiotic?

You will be carefully monitored for any side effects, but antibiotics can sometimes cause mild reactions like stomach upset. The study team will explain everything carefully.

How long will I need to be in the study centre?

You will need to stay for specific periods during which measurements are taken, typically a day or two for each session, with breaks in between.

Do I need to pay to join the study?

No, you will not have to pay to participate. You will likely be paid for your time and inconvenience.