Randomized, crossover, two-period, two-treatment, comparative bioavailability study of ibuprofen (arginine) granules for oral solution, developed by Farmalider, S.A., and Espidifen® granules for oral solution, administered in single dose of 600 mg to healthy subjects under fasting conditions.
This research study is looking at a new ibuprofen medicine in a sachet that you mix with water, developed by a company called Farmalider. We want to see how well your body takes in this new ibuprofen compared to an existing ibuprofen medicine called Espidifen, which also comes as a sachet to mix with water. Both medicines contain 600mg of ibuprofen. Healthy volunteers will take a single dose of each medicine on different days, after not eating for a while. This helps us ensure that the new ibuprofen is absorbed effectively and works properly, just like medicines that are already available. It's a very early stage study to understand how the medicine behaves in the body.
At a glance
What is this study about?
Imagine you have a headache and you take some ibuprofen. You want it to work quickly and effectively, right? This study is designed to check if a new version of ibuprofen, which comes as granules you mix into a drink, works just as well inside your body as a similar ibuprofen medicine that's already used. It's a bit like comparing two different brands of soluble aspirin to see if they both get into your system at the same speed and to the same amount.
The main goal is to understand how much of the ibuprofen from the new granules gets into your bloodstream, and how quickly. This is important because it tells us if the medicine is absorbed properly and if it will be effective when people take it for pain. Doctors and scientists call this 'bioavailability' – essentially, how much of the medicine is available to act in your body. If the new ibuprofen product has similar bioavailability to the existing one, it means it's likely to be just as effective.
This kind of study is a very early step in bringing a new medicine to people. It helps the company make sure their new ibuprofen product is reliable and works as expected before it can be considered for wider use. It's not about treating any illness, but simply about understanding how the medicine behaves in healthy people.
Key takeaways
- It's comparing a new ibuprofen medicine to an existing one.
- The study looks at how ibuprofen is absorbed in healthy adults.
- Participants will take a single dose of each medicine on separate days.
- Blood samples will be taken to measure medicine levels in the body.
- This is an early-stage study, not for treating any condition.
Who may be eligible?
This study is looking for healthy adults to take part. To be eligible, you need to be at least 18 years old, and there's no upper age limit as long as you are generally healthy.
Being 'healthy' means you don't have any major ongoing health conditions that would affect how your body handles medicines. For example, you wouldn't be able to join if you had significant heart problems, kidney disease, or liver disease. The researchers will carry out some checks to make sure you're suitable.
Both men and women are welcome to take part in this study. The most important thing is that, apart from maybe a minor cold, you should be feeling well and not taking any regular medication that could interfere with the ibuprofen.
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.
- I am 18 years old or older.
- I consider myself to be generally healthy.
- I am able to visit the clinic on two separate occasions.
- I am comfortable with having blood samples taken.
- I am not currently taking any regular medication that might interfere with ibuprofen (check with study staff).
What does participation involve?
If you decide to take part, you'll visit the study clinic on two separate occasions. On each visit, you'll receive a single dose of one of the ibuprofen medicines (either the new one or the existing one). You'll be asked not to eat anything for a certain period before taking the medicine, and likely for a little while afterwards, too.
The study is called a 'crossover' study, which means you'll try both medicines. You'll take one medicine on the first visit, and the other medicine on the second visit. This helps researchers compare the two medicines fairly in the same person. There will be a 'washout period' between the two visits, which means a break of some days to make sure the first medicine has completely left your body before you take the second one.
During each visit, healthcare professionals will take regular blood samples to measure how much ibuprofen is in your system over several hours. They might also check your blood pressure and heart rate. You won't be given any other medicines as part of the study, and your total participation, including both visits and the break in between, will be relatively short, likely over a few weeks.
Potential risks and benefits
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Common questions
What is ibuprofen (arginine)?
It's a form of ibuprofen mixed with arginine, which is thought to help the ibuprofen dissolve and be absorbed faster in your body compared to regular ibuprofen.
Why is this study only looking at healthy people?
Early studies like this use healthy volunteers to understand how the medicine works in a 'typical' body, without other health conditions or medicines complicating the results.
Will I know if I'm getting the new ibuprofen or the already available one?
The study design sometimes involves you knowing, or it might be 'blinded' where neither you nor the staff know which you are taking at the time. The researchers will explain this to you.
How long will each study visit last?
Each visit will likely involve several hours at the clinic to allow for blood samples to be taken at different times after you take the medicine.
Do I need to pay to take part?
No, you will not have to pay anything to participate. In fact, you may be compensated for your time, travel, and inconvenience.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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