A single-dose, open-label, randomized, two-period, two-sequence, crossover pivotal bioequivalence study on 400 mg / 5 mL amoxicillin + 57 mg / 5 mL of clavulanic acid powder for oral suspension in healthy volunteers under fed conditions.
This is a study for healthy adults comparing a new liquid antibiotic, Amoxicillin and Clavulanic Acid (used for infections), with a commonly used version. We want to check if the new medicine is absorbed into the body in the same way as the established one, especially when taken after food. This is called a 'bioequivalence' study. It helps ensure that any new version of a medicine works just as effectively and safely as the original. Participants will take both medicines at different times, allowing researchers to directly compare how each one behaves in the body. This is a vital step before a new medicine can be widely used.
At a glance
What is this study about?
Imagine you have an infection, and your doctor prescribes an antibiotic. Sometimes, a drug company might want to create a new version of an existing medicine – perhaps it's a liquid form that's easier to swallow than a tablet, or it's made by a different manufacturer. Before this new version can be given to patients, we need to be absolutely sure it works just as well and is just as safe as the original.
That's where this study comes in. It's looking at a new liquid form of a common antibiotic called Amoxicillin and Clavulanic Acid, which is used to treat various infections. The main goal is to check if this new liquid medicine is absorbed by the body in the same way and to the same extent as a well-known, existing liquid version. This process is called proving 'bioequivalence' – essentially, proving that the new version is biologically the same as the old one when it comes to how your body handles it.
This study is done in healthy volunteers because it allows researchers to see how the medicine behaves without the effects of an illness, making the results clearer. Participants will take the medicine after eating because food can sometimes change how drugs are absorbed. By carefully comparing both medicines, scientists can confidently say whether the new liquid antibiotic will be just as effective for patients as the current one.
Key takeaways
- Compares a new liquid antibiotic with an existing one.
- Checks if they work the same way in healthy adults.
- Medicines are taken after eating.
- Participants take both medicines at different times.
- Aims to ensure new medicines are safe and effective.
- A study for healthy volunteers aged 18 and over.
Who may be eligible?
This study is looking for healthy adult volunteers. To take part, you need to be at least 18 years old – there's no upper age limit, as long as you're in good general health.
Doctors and nurses will carefully check your health to make sure it's safe for you to take part. This usually involves health questionnaires, a physical check-up, and blood tests to confirm you're healthy and don't have any underlying medical conditions that could be affected by the study medicines.
Things that might stop you from joining include having certain health conditions, taking other medications that could interfere, or if you've recently been part of another clinical study. The study team will explain all the specific requirements in detail.
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 at least 18 years old?
- Are you generally healthy?
- Are you able to attend study visits as required?
- Are you able to follow study instructions carefully?
- Are you not currently pregnant or breastfeeding (for women)?
What does participation involve?
If you decide to take part, you'll visit the study clinic two separate times. During each visit, you'll be given one of the liquid antibiotic medicines to take after eating a standard meal. You won't know if you're getting the new or existing version first; this is decided randomly. After taking the medicine, the study team will take several blood samples over a set period to see how the medicine is absorbed and leaves your body. You'll switch medicines on your second visit.
Between these two visits, there will be a 'washout' period, which means a certain amount of time will pass to make sure the first medicine has completely left your system before you take the second one. The total time you'll be involved in the study, including all visits and the washout period, will be explained fully by the study team.
Potential risks and benefits
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Common questions
What kind of infection does this antibiotic treat?
This study focuses on a general antibiotic used for various common bacterial infections. The study isn't about treating an infection you currently have, but rather understanding how the medicine works in healthy people.
Will I get paid to take part?
Many healthy volunteer studies offer payment for your time and inconvenience. The study team will inform you if this study offers compensation.
Do I need to stay at the clinic overnight?
The study description doesn't specify. The study team will provide full details about the length of each visit and if any overnight stays are required.
What happens if I have a side effect?
The study team will monitor you closely during and after you take the medicine. If you experience any side effects, they are there to provide care and guidance.
Can I eat and drink normally during the study?
You will be given a standard meal before taking the study medicine. Other than that, the study team will provide specific instructions about what you can and can't eat or drink during your visits.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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