A Single Dose, Two – stage, Fasting State, Bioequivalence Study of Rifaximin 200 mg, film-coated tablets (Antibiotice S.A.) vs. Normix® 200 mg, film-coated tablets (Alfasigma S.p.A)
This study is designed to compare two different versions of a medicine called rifaximin (200mg tablets). Rifaximin is an antibiotic. We want to see if the new version, made by Antibiotice S.A., is absorbed and behaves in the body in the same way as the original, approved version, Normix®, made by Alfasigma S.p.A. This type of study, called a 'bioequivalence study,' is a standard and important step when a new company wants to make a generic version of an existing medicine. It helps ensure that patients will get the same treatment benefits and safety, no matter which version they are prescribed. Healthy adult volunteers are needed for this research.
At a glance
What is this study about?
Imagine you take a paracetamol tablet for a headache. What if a different company makes their own paracetamol tablet? This study is similar. It's looking at an antibiotic called rifaximin, specifically comparing a new version of the 200mg tablet to an existing, approved one. The main goal is to check if both tablets deliver the same amount of the medicine into your body at the same speed. This is really important because it means the new version should work just as well and be just as safe as the original.
This kind of research is called a 'bioequivalence study.' It's a key part of how new medicines become available. Before a new, often more affordable, version of a medicine can be used by patients, it must be rigorously tested to prove it's the same as the original. This makes sure that when your doctor prescribes rifaximin, you can be confident that whichever brand you receive will treat you effectively.
By taking part, you would be helping medical science ensure that new medicines are consistently high quality and reliable for everyone. It's a routine but vital step that helps improve access to important treatments.
Key takeaways
- This study compares a new antibiotic tablet to an existing one.
- It checks if both versions are absorbed equally by the body.
- Healthy adult volunteers (aged 18+) are needed.
- Participation involves taking a single dose and blood tests.
- It helps ensure new medicines are safe and effective.
- You can withdraw at any time.
Who may be eligible?
This study is looking for healthy adults to take part. This means people aged 18 and over, with no upper age limit. Both men and women are welcome.
'Healthy' in a study means you generally don't have any major ongoing health problems or illnesses that could affect how your body responds to the medicine being tested. It's important for this type of research that participants are in good general health so that the results clearly show how the medicine behaves in a typical body.
When you inquire about the study, the research team will ask you some questions about your health and will also do some checks to make sure taking part is safe for you and that you meet all the specific requirements. They will explain everything clearly.
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 in good health?
- Are you able to follow study instructions, including fasting?
- Are you available for clinic visits and follow-up checks?
What does participation involve?
If you decide to take part, you would first have a screening visit to check if you are suitable. This might involve a discussion about your health, a physical check-up, and some blood tests. If you meet the criteria, you would then come to the clinic for the study days.
The study involves taking a single dose of one of the rifaximin tablets after a period of not eating (fasting). You would then have several blood samples taken over a set period of time to see how the medicine is absorbed and leaves your body. This usually means you'd stay at the clinic for a certain number of hours, or even a full day, after taking the medicine. There might be some follow-up checks after you leave the clinic, such as a phone call or another short visit, to make sure you are feeling well. The total time you would be involved in the study would be explained fully by the study team.
Potential risks and benefits
Locations (1)
- —UnverifiedRomania
Common questions
What is rifaximin?
Rifaximin is an antibiotic medicine often used to treat certain gut-related infections and conditions.
What does 'bioequivalence' mean?
It means we are checking if two different versions of the same medicine work in the same way in the body.
Will I get the new medicine or the original one?
You might get either the new version or the original version, but the study is designed so that neither you nor the researchers will know which one you received until after the study is over, to keep the results fair.
Do I need to be ill to join?
No, this study specifically needs healthy volunteers to understand how the medicine works in typical people.
Will I be paid for taking part?
Many clinical trials offer some payment for your time and inconvenience. The study team will tell you if this applies.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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