Randomized, crossover, comparative bioavailability study of two Paracetamol-Ibuprofen 25-20 mg/ml oral suspension, administered in single dose to healthy subjects under fasting conditions.
This research study is comparing two different liquid medicines that both contain paracetamol and ibuprofen. We want to understand how each medicine is handled by your body, specifically how much of the medicine gets into your bloodstream and how fast it gets there. This information helps us ensure new medicines work as expected. The study involves healthy adult volunteers taking a single dose of one medicine, and then after a break, taking a single dose of the other medicine. This helps us make a fair comparison. If you're generally healthy and interested in helping medical science, this study could be for you.
At a glance
What is this study about?
Imagine you have a new flavour of your favourite fizzy drink, but you also want to try a different brand to see if it tastes the same or better. That's a bit like what this study is doing with medicines. We're looking at two different liquid medicines that both contain the well-known pain relievers paracetamol and ibuprofen. They are made by different companies, or perhaps in slightly different ways.
The main goal is to see how your body absorbs these medicines. When you take a medicine, your body needs to take it in from your stomach or gut into your bloodstream so it can travel to where it's needed. We want to measure how much of the paracetamol and ibuprofen from each liquid medicine gets into your blood, and how quickly it gets there. This helps us make sure that both medicines work effectively and are consistent in how your body uses them.
Studies like this are very important because they help confirm that new versions of medicines are just as good as existing ones. It means that when you buy a medicine from a pharmacy, doctors and pharmacists can be confident that you're getting the right amount of active ingredient and that it will work in the way it's supposed to. It's an early step in testing medicines, and it's always done with healthy volunteers first to make sure it's safe.
Key takeaways
- Compares two liquid paracetamol-ibuprofen medicines.
- Checks how your body absorbs each medicine.
- For healthy adults aged 18 and over.
- Involves temporary fasting and blood tests.
- Single doses of each medicine on separate occasions.
- Contributes to understanding medicine effectiveness.
Who may be eligible?
This study is looking for healthy adults. You need to be at least 18 years old to take part, and there isn't an upper age limit as long as you are generally healthy. Both men and women are welcome to join this study.
Being 'healthy' for a study like this usually means you don't have any major ongoing health conditions that would affect how your body handles medicines. For example, conditions that affect your liver, kidneys, or stomach might mean you can't join.
More specific details about what counts as 'healthy' will be discussed during the screening process with the study team. They will ask you questions about your medical history and might do some basic health checks to make sure the study is safe for you.
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?
- Do you consider yourself generally healthy?
- Are you comfortable with blood tests?
- Can you follow instructions for fasting?
- Are you able to commit to several clinic visits?
What does participation involve?
If you decide to take part, you'll visit the study clinic on a few occasions. In this type of study, you'll usually take part in two separate 'study periods'. In each period, you'll receive a single dose of one of the liquid medicines (either the first or the second type).
Before taking the medicine, you'll be asked to fast, meaning you won't eat or drink anything (except water) for a certain number of hours. After taking the medicine, the study team will take several blood samples over a set period, usually a few hours, to measure how the medicine is absorbed into your body. They'll also monitor you for any side effects. You'll then have a break before coming back for the second study period to take the other medicine, following a similar process. The total duration of your participation, including all visits and follow-up, will be explained in full by the study team.
Potential risks and benefits
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Common questions
What is 'bioavailability'?
It's a scientific term that basically means how much of a medicine actually gets into your bloodstream and how quickly it gets there when you take it.
Why do I need to fast before taking the medicine?
Fasting helps ensure that food in your stomach doesn't affect how the medicine is absorbed, so we can get a clearer picture of how the medicine itself works.
Will I know which medicine I'm offered?
In a 'crossover' study, you get both medicines at different times, but it might be 'blinded' meaning neither you nor the study team knows which one you're taking at a given time, to keep things fair.
How many blood samples will be taken?
The exact number will be explained by the study team, but typically several samples are taken over a few hours to track the medicine's levels in your blood.
Will I get paid for taking part?
Often, volunteers for these types of early-phase studies receive some payment for their time, travel, and inconvenience. This will be clearly explained before you agree to participate.
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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