A single dose, randomized, open-label, three-way crossover study to assess bioequivalence of paracetamol orodispersible tablets 500 mg vs Apiretal® 100 mg/ml oral solution in healthy volunteers under fasting conditions
This research study is about two types of paracetamol: a tablet that dissolves quickly in your mouth (500 mg) and a liquid syrup (Apiretal® 100 mg/ml). We want to see how well each one is absorbed into the body when taken by healthy adults on an empty stomach. This is called a 'bioequivalence' study, and it helps ensure that different versions of a medicine work in much the same way. Volunteers will try both types of paracetamol on separate occasions, allowing researchers to compare their effects fairly. This type of study is an early step in testing medicines and is done to make sure new forms of existing drugs are just as effective.
At a glance
What is this study about?
Imagine you have a new type of paracetamol that melts quickly in your mouth. Doctors and pharmacists need to know if it works just as well as the liquid paracetamol you might give to a child. That's what this study is all about. We're looking to see how much of the paracetamol from each form (the melting tablet and the liquid medicine) actually gets into your bloodstream and how quickly.
This is important because even if two medicines contain the same active ingredient (like paracetamol), the way they're made can affect how your body uses them. By comparing them, we can be confident that patients will get the right amount of medicine, whether they take a tablet or a liquid. This type of research is a key part of making sure medicines are safe and effective for everyone.
This study is called a 'bioequivalence' study. Think of it as making sure two different keys can open the same lock when they're supposed to. We're testing whether the melting tablet key and the liquid key work just as effectively to deliver paracetamol to your body.
Key takeaways
- This study compares how two paracetamol forms are absorbed.
- It helps ensure different paracetamol products work similarly.
- Healthy adults (18+) are needed, both men and women.
- You'll take both a melting tablet and liquid paracetamol on different days.
- You'll need to fast (not eat) before taking the medicine.
- Your blood will be checked to see how the paracetamol is absorbed.
Who may be eligible?
This study is looking for healthy adults. You need to be 18 years old or older to take part. There's no upper age limit, so adults of all ages are welcome.
Both men and women can participate in this study. The main requirement is that you are generally healthy and don't have any ongoing medical conditions that might affect how your body handles medicines.
Because we are studying how the medicine is absorbed, you would need to be able to follow instructions about not eating for a certain period before taking the medicine.
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 able to follow instructions about not eating before taking medicine?
- Are you willing to have blood samples taken?
- Are you available for several clinic visits?
What does participation involve?
If you decide to join this study, it will involve several visits to a clinic. On different occasions, you will be given either the paracetamol melting tablet or the liquid paracetamol after you haven't eaten for a while (fasting). Researchers will then take blood samples at set times after you've taken the medicine to measure how much paracetamol is in your body.
This study uses a 'crossover' design, meaning you will try both types of paracetamol, but on different days. This helps the researchers get a very clear comparison. The total duration of your participation, including all visits and follow-up, will be explained in full detail before you agree to take part.
Potential risks and benefits
Locations (1)
- —UnverifiedSpain
Common questions
What does 'healthy volunteers' mean?
It means people who generally don't have any major ongoing health problems or illnesses.
Why do I need to be 'fasting'?
Fasting means not eating for a certain time before taking the medicine. This helps researchers see how the medicine is absorbed without food affecting it.
What is 'bioequivalence'?
It means checking that two different forms of the same medicine work in a very similar way inside your body.
Will I receive any payment for taking part?
Often, studies like this offer payment for your time and inconvenience. This will be fully explained before you consent.
Is paracetamol safe to take in a study?
Paracetamol is a common over-the-counter medicine. The study will be designed to use it safely, and you'll be monitored closely.
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.