Randomized, Open-label, Single-Dose, Two-treatment, Two-period, Cross-over, Pivotal Bioequivalence Study Comparing Amoxicilin/Clavulanic acid powder for oral suspension 600 mg/42.9 mg/5 mL to Augmentin ES 600 mg/42.9 mg/5 mL powder for oral suspension in Healthy Adult Male and Female Volunteers under Fed Conditions.
This study is comparing a new liquid antibiotic (Amoxicillin/Clavulanic acid) with a well-known one called Augmentin ES. Both are powders that you mix to make a liquid medicine. We're testing if the new liquid medicine is handled by the body in the exact same way as Augmentin ES. This kind of study, called a bioequivalence study, is important because it makes sure that if you take a new version of a medicine, it will work just as effectively as the original. Healthy adult men and women will take part, and they will receive both medicines at different times, always after eating. We'll be looking at how much of the medicine gets into the blood and how quickly.
At a glance
What is this study about?
Imagine you have a well-known, effective antibiotic medicine that's been around for a while. Sometimes, other companies want to make their own version of that medicine. Before these new versions can be used by patients, it's really important to prove they work just as well as the original. That's what this study is all about.
This particular study is comparing a new liquid antibiotic, which is a mix of Amoxicillin and Clavulanic acid, with a well-known one called Augmentin ES. Both are given as a powder that you mix with water to make a liquid medicine. The main goal is to find out if the body absorbs and processes the new liquid medicine in the same way, and to the same extent, as the established Augmentin ES. This ensures that when you take the new version, you'll get the same benefits as the original.
To do this, healthy adult volunteers will take both medicines at different times. By giving each person both medicines, scientists can see how their body reacts to each one under the same conditions. They'll measure things like how much medicine gets into the bloodstream and how quickly, to ensure the new medicine is 'bioequivalent' – meaning your body handles it almost identically to the original. This is a standard and crucial step in bringing new medicines to people.
Key takeaways
- This study compares a new liquid antibiotic to a standard one.
- It's for healthy adult men and women, aged 18 and over.
- The goal is to ensure the new medicine works just as well as the original.
- Volunteers will take both medicines and have blood samples taken.
- Participation helps make new medicines safe and effective.
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 mentioned, so older adults can also participate as long as they are generally healthy.
Both men and women are welcome to join this study. As it's designed for 'healthy volunteers,' you shouldn't have any major ongoing health conditions or be taking medicines that could affect the study results. The exact details of what 'healthy' means will be carefully checked by the study doctors.
Since this study involves comparing how your body handles medicines, the doctors will do a thorough health check to make sure it's safe for you to take part and that your body won't react in an unusual way to the antibiotics.
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?
- Are you available for clinic visits and blood tests?
- Are you able to take oral liquid medication?
- Are you comfortable having regular blood samples taken?
What does participation involve?
If you decide to take part, you'll be given both the new liquid antibiotic and the well-known Augmentin ES at different times during the study. You'll always take the medication after eating a meal. This is a 'cross-over' study, which means you'll get one medicine first, then after a break, you'll get the other medicine. This helps compare the two medicines in the same person.
Taking part will involve visits to the study clinic where you'll receive the medication. After you take the medicine, the doctors and nurses will regularly take blood samples to measure how much of the antibiotic is in your system. This helps them understand how your body absorbs and deals with the medicine. You will also have regular health checks.
There will be two separate periods where you take medication and have blood tests, with a 'washout' period in between. The total duration of your participation, including all visits and follow-up, will be explained fully by the study team. They will ensure you understand all the steps involved.
Potential risks and benefits
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Common questions
What is Amoxicillin/Clavulanic acid?
It's an antibiotic medicine that helps treat bacterial infections. It's often used for things like ear infections, sinus infections, and bronchitis.
What does 'bioequivalence' mean?
It means we're checking if a new version of a medicine works in your body in the exact same way as an older, well-known version. So, if they are 'bioequivalent,' you can expect the same effect.
Will I get both medicines?
Yes, you will receive both the new liquid antibiotic and the established Augmentin ES at different times during the study, always after a meal.
Do I need to be ill to join this study?
No, this study is actually for generally healthy adult volunteers, not for people who are currently sick with an infection. We need healthy people to understand how the medicine works normally.
What is Augmentin ES?
Augmentin ES is a common brand name for another liquid antibiotic that contains Amoxicillin and Clavulanic acid, similar to the one being tested.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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