A single-dose, open-label, randomized, two-period, two-sequence, crossover pivotal bioequivalence study on Taromentin® 500 mg + 125 mg film-coated tablets versus Augmentin® 500 mg + 125 mg film-coated tablets in healthy volunteers under fed conditions.
This study is looking at an infection-fighting medicine called Taromentin, to see if it works in the same way as a well-known medicine called Augmentin. Both medicines contain the same active ingredients (500 mg amoxicillin and 125 mg clavulanic acid) and are used to treat infections. We need healthy adult volunteers to take a single dose of each medicine, at different times, after they've had a meal. This helps us understand how the body absorbs and uses the medicines. It’s a very common and important type of study to make sure new medicines are just as effective and safe as existing ones. This is a short study, focusing on how the medicines behave in the body, not on treating an illness.
At a glance
What is this study about?
Imagine you have an infection, and your doctor prescribes an antibiotic. There are often several brands of the same antibiotic available. This study is like checking if two different brands of the same popular antibiotic medicine work in exactly the same way inside your body. The medicines are called Taromentin and Augmentin, and they both help fight infections.
Specifically, researchers want to see if the Taromentin tablet acts identical to the Augmentin tablet when taken by healthy people after eating food. They'll be looking to see if the main ingredients from both medicines get into the bloodstream in the same amounts and at the same speed. This is a crucial step to ensure that if Taromentin is prescribed, it will be just as effective and safe as Augmentin, which doctors are already familiar with.
This kind of study, called a bioequivalence study, is very common and important for bringing new medicines to market. It's not about testing if the medicine cures an infection, but rather watching how the body handles the medicine itself. It helps regulatory bodies, like the NHS in the UK, be confident that different brands of the same medicine can be used interchangeably.
Key takeaways
- Compares two antibiotic medicines, Taromentin and Augmentin.
- Aims to check if Taromentin works the same as Augmentin in the body.
- Involves healthy adult volunteers (18+ years old).
- Requires taking single doses of each medicine after food.
- Blood samples will be taken to measure medicine levels.
- Participation helps bring new, approved medicines to patients.
Who may be eligible?
This study is looking for healthy volunteers. This means you should not have any ongoing health problems or illnesses that might affect how your body handles the medication. The researchers will have specific health checks to make sure you are suitable and fit for the study.
You need to be an adult to take part. This means you must be at least 18 years old. There is no upper age limit, so as long as you are healthy, you can be considered.
Both men and women are welcome to participate in this study. The researchers want to include a variety of people to get a good understanding of how the medicines work.
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 serious medical conditions?
- Are you able to attend clinic visits as required?
- Are you comfortable with having blood samples taken?
- Are you able to follow specific instructions (e.g., about food or other medicines)?
What does participation involve?
If you decide to take part, you'll visit the clinic on a few occasions. On two separate visits, you will receive a single dose of one of the study medicines (either Taromentin or Augmentin) after you've had a meal. You won't know which medicine you're getting each time, and sometimes researchers won't know either.
During each visit, blood samples will be taken regularly over several hours. This helps the researchers measure how much of the medicine's ingredients are in your bloodstream. You might also have some general health checks, like blood pressure or temperature readings. There will be a 'washout' period between the two doses, meaning a gap of time where you don't take any study medication, to make sure the first dose is completely out of your system before you take the second.
The total time you'd be involved in the study, including all visits and the break between doses, will be clearly explained to you by the study team. They will also tell you if there are any dietary restrictions or other instructions you need to follow before or during the study.
Potential risks and benefits
Locations (1)
- —UnverifiedCzechia
Common questions
What kind of medicines are Taromentin and Augmentin?
They are both antibiotic medicines, used to treat bacterial infections. They contain the same active ingredients.
Why do I need to be healthy to join this study?
Because the study wants to see how the medicines work in a normal, healthy body, without other illnesses affecting the results.
Will I get paid for taking part?
Yes, usually volunteers receive payment for their time, travel, and any inconvenience caused by participating in the study.
What happens if I feel unwell during the study?
The study team will monitor you closely. If you feel unwell, you should tell them immediately. Your safety is their top priority.
Do I have to eat before taking the medicine?
Yes, for this specific study, you will take the medicine after having a meal. This sometimes changes how a medicine is absorbed.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.