A comparative bioavailability of reformulated ibuprofen 2% and 4% oral suspensions (Berlin Chemie AG) and reference ibuprofen (Nurofen®) 200 mg/5 ml oral suspension in healthy male and female adult subjects under fasting conditions: an open-label, randomized, single-dose, three-period, three-treatment, three-sequence crossover study
This study is looking at new liquid forms of ibuprofen, a common pain reliever. Specifically, it wants to see how well two new ibuprofen syrups (2% and 4% strength) are absorbed into the body compared to a familiar one called Nurofen® syrup (200 mg/5ml). Researchers will give single doses of each ibuprofen type to healthy adult volunteers on different occasions. The main goal is to check if the new ibuprofen liquids deliver the medication to the body in a similar way to the established one. This type of study, called a bioequivalence study, is important to make sure that when new versions of medicines are developed, they work just as effectively as the original.
At a glance
What is this study about?
This study is all about ibuprofen, a medicine many of us use for pain and fever. You might know it as Nurofen®, Brufen, or just ibuprofen. When a company wants to introduce a new version of a medicine, especially a liquid one, they need to make sure it works just as well as what's already out there. This particular study is comparing two new liquid ibuprofen medications (at 2% and 4% strength) to a familiar ibuprofen syrup (Nurofen® 200 mg/5ml).
The main purpose of this study is to see if the new ibuprofen liquids are 'bioequivalent' to the established one. In simple terms, this means checking if your body absorbs the ibuprofen from the new liquids at the same speed and in the same amount as it does from the Nurofen® syrup. This is really important because it ensures that if these new medicines become available, they will be just as effective and safe as the ones you might already be using.
So, why does this matter to you? If you or your family ever need liquid ibuprofen, studies like this help guarantee that any new options on the market will work predictably and reliably. It's a crucial step in bringing new, trustworthy medicines to people. This study focuses on healthy volunteers because we want to see how the medicines behave in people without other health conditions that might change how their body processes the drug.
Key takeaways
- This study compares new ibuprofen liquids with a standard one.
- It aims to ensure new medicines are absorbed correctly.
- Only healthy adult volunteers are needed.
- Participation involves taking single doses and giving blood samples.
- It helps contribute to safer and more effective medicines.
Who may be eligible?
This study is looking for healthy adults to take part. This means you shouldn't have any significant medical conditions or ongoing illnesses. The researchers want to understand how ibuprofen medicines work in people generally, rather than those with specific health problems.
To be eligible, you need to be an adult, aged 18 years or older. There is no upper age limit mentioned, as long as you are considered generally healthy. Both men and women are welcome to participate in this study.
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 major medical conditions?
- Are you comfortable fasting before taking medication?
- Are you able to attend multiple study visits for blood tests?
- Are you female or male?
What does participation involve?
If you join this study, you'll be asked to take part in three separate sessions. In each session, you will receive a single dose of one of the ibuprofen medicines — either one of the new liquid formulations or the Nurofen® syrup. You'll switch which medicine you receive each time, so over the course of the study, you will have tried all three.
To ensure the best results, you'll be asked to come in after fasting, meaning you won't have eaten for a certain number of hours before taking the medicine. After you take the dose, nurses and doctors will regularly take small blood samples. These samples help them measure how much ibuprofen is in your body and how quickly it gets there. There will be breaks between each of the three sessions to allow the medicine to completely leave your system. The total duration of your involvement, from the first dose to the final check, will depend on the schedule set by the study team, but typically these types of studies can span several weeks, with each dosing period lasting a day or two.
Potential risks and benefits
Locations (1)
- —UnverifiedLithuania
Common questions
What is 'fasting' in this study?
Fasting means you won't eat or drink anything (except water) for a certain number of hours before taking the medicine. This ensures the study results aren't affected by food.
Will I know which medicine I'm getting?
Yes, this is an 'open-label' study, which means both you and the study team will know which ibuprofen liquid you are receiving during each session.
What does 'bioequivalence' mean?
It means the study is checking if the new ibuprofen liquids get into your body at the same speed and in the same amount as a well-known ibuprofen syrup, ensuring they work similarly.
Do I need to be ill to join?
No, quite the opposite! This study is specifically looking for healthy adults without any ongoing medical conditions.
Will I get paid for participating?
The study information provided doesn't mention payment. It's best to ask the study team directly if financial compensation is offered for your time and travel.
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.