Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence of Amoxicillin and Clavulanic Acid 250 mg/62.5 mg/5 mL Powder for Oral Suspension versus Augmentin® Forte 250 mg/62.5 mg/5 mL Powder for Oral Suspension in Healthy Participants Under Fed Conditions

This study is comparing a new version of an antibiotic with an older, well-known one. The antibiotic contains two medicines: amoxicillin and clavulanic acid, often used to treat infections. Researchers want to make sure the new version is absorbed into the body in the same way as the original when taken by mouth. This is important to ensure it works just as effectively and is as safe. We're looking for healthy adults to take part. They will take the medicine after they've eaten. This type of study, called a bioequivalence study, helps new medicines become available to people at potentially lower costs, while still providing the same trusted effect.

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?

This research study is focused on a common antibiotic that's used to treat various infections. This particular antibiotic is a combination of two active ingredients: amoxicillin and clavulanic acid. You might know the original version by the brand name like Augmentin® Forte.

The main goal of this study is to compare a new, generic version of this antibiotic to the original one. We want to check if the new version is absorbed into the body in the same way and at the same speed as the original when taken by mouth. This is called 'bioequivalence'. If two medicines are bioequivalent, it means they are expected to have the same effects and safety profiles.

This is an important step before a new medicine can be widely used. Ensuring bioequivalence means that patients can take the new version with confidence, knowing it will work just as effectively as the original. It can also help make important medicines more accessible and affordable for more people.

Key takeaways

Compares a new antibiotic to an existing one.
Checks if they work the same way in the body.
Looking for healthy adults (18+).
Medicine taken after a meal.
Helps ensure new medicines are safe and effective.

Who may be eligible?

This study is looking for healthy adult volunteers. You must be at least 18 years old to take part. There is no upper age limit specified, so older adults who are otherwise healthy may also be able to join.

Since this is a study for healthy people, you should not have any ongoing medical conditions or be taking long-term medications, other than perhaps common over-the-counter vitamins or very specific prescribed medicines that don't interfere with the study drug. The research team will carefully check your health to make sure it's safe for you to participate.

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 major medical conditions?
Are you not taking any regular prescription medications that might interfere with antibiotics?
Are you able to attend appointments for health checks and blood tests?

Answer every question to see your result.

What does participation involve?

We are not provided with details on what being in the study involves, such as the number of visits, specific tests, or how long the study will last. However, in studies like this, participants typically undergo a health check-up before starting. You would then receive the study medication (the new antibiotic or the original one) on one or more occasions, usually after eating a standardised meal. Blood samples would likely be taken at set times after you take the medicine to measure how much of it is in your body. There would also be follow-up checks to make sure you're feeling well. The total time you'd spend in the study, including visits and follow-ups, would be explained fully by the study team.

Potential risks and benefits

Participating in research can offer a sense of contributing to medical science. For this type of study, potential risks are generally similar to those of taking the antibiotic itself, such as tummy upsets, or allergic reactions, though these are rare. There might also be discomfort from blood draws. You will be closely monitored by medical staff for your safety. Remember, you can choose to leave 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 'bioequivalence'?

It means we're checking if a new medicine works in the body in the exact same way as an older, established one.

Why is this study needed?

It helps make sure that new, potentially more affordable versions of medicines are just as safe and effective as the original ones.

Who can take part in this study?

We are looking for healthy adults, aged 18 and over, who are not on any medications that would interfere with the study.

Will I get the new antibiotic or the old one?

You might get either the new version or the original. The study will compare how both are absorbed in your body.

What does taking the medicine 'under fed conditions' mean?

It means you will take the study medicine after you have eaten a meal, as this can affect how your body absorbs it.