Characterisation of availability in the body of the active substance(s) of the newly developed patch Esflurbiprofen Topical System (EFTS) in comparison with a marketed oral flurbiprofen-containing tablet formulation after multiple dose administration including adhesion assessment of the patch - a phase I, open-label, randomised, 2-period, cross-over study in healthy subjects
This study is looking at a new type of sticky patch called Esflurbiprofen Topical System (EFTS) that delivers medicine through the skin. We want to see how much of the medicine from this new patch gets into your body compared to taking a regular tablet for pain relief. We'll also be checking how well the patch stays on your skin. This is an early-stage study involving healthy adult volunteers, not people with a specific illness. The main goal is to understand how the medicine travels through the body, rather than studying its effects on a particular condition. It involves comparing the patch and the tablet over two separate periods.
At a glance
What is this study about?
Imagine you have a new way to get medicine into your body, like a sticky patch you put on your skin. This study is all about understanding how well a new patch, called Esflurbiprofen Topical System (EFTS), works in getting its medicine into your system compared to a common pain-relief tablet that you swallow. Think of it like comparing two different ways to deliver a package: one by post and one by courier – we want to see which one delivers the contents most effectively and predictably.
Specifically, researchers want to see how much of the medicine from the patch actually gets absorbed into your bloodstream. This is important information because it helps them understand if the patch delivers medicine in a consistent and useful way. They'll also be looking at how well the patch sticks to your skin, which is crucial for it to work properly.
This is an early-stage study, meaning it's one of the first times this new patch is being studied in people. It’s for healthy volunteers and is designed purely to gather information about how the medicine behaves in the body, not to treat any specific illness. This kind of research is vital for developing new medicines safely and effectively in the future.
Key takeaways
- Tests a new medicine patch against a tablet.
- Checks how much medicine gets into the body.
- Also assesses how well the patch sticks.
- For healthy people aged 18 and over.
- Involves clinic visits and blood tests.
- Helps develop future medicines, not a treatment.
Who may be eligible?
This study is looking for healthy adults. You would need to be at least 18 years old to take part.
It’s important to remember that this study is not for people who are unwell or have ongoing health conditions. Because the main goal is to understand how the medicine is absorbed, volunteers need to be generally healthy so that other health factors don't confuse the results.
The researchers haven't mentioned any other specific things that would stop you from taking part, like your gender. If you’re a healthy adult over 18, and this study sounds interesting, it’s worth discussing it further with the study team.
- Are you 18 years old or older?
- Are you generally healthy with no serious long-term health conditions?
- Are you comfortable visiting a clinic for multiple appointments?
- Are you willing to have blood samples taken regularly?
- Are you able to follow study instructions carefully?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you'll be involved in what's called a 'cross-over study'. This means you'll try both the new patch and the tablet at different times, with a break in between. The order in which you receive them will be decided randomly, like flipping a coin.
During the study periods, you will have several visits to the study clinic. These visits will involve having blood samples taken regularly to measure how much of the medicine is in your body. They will also check how well the patch stays on your skin. You'll likely receive the medication (either the patch or the tablet) on-site and be monitored for a period afterward. The total duration of your involvement, including all visits and follow-up, will be explained in detail by the study team.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What kind of medicine is in the patch?
The patch contains a medicine called esflurbiprofen, which is related to common pain relief medicines like flurbiprofen.
Will this study help me with a specific health problem?
No, this study is not designed to treat an illness. It's about understanding how a new medicine is absorbed by healthy people.
Do I have to take both the patch and a tablet?
Yes, you will try both the patch and the tablet at different times during the study so researchers can compare them.
How often will I need to visit the clinic?
You will have several clinic visits during the two separate periods of the study, and these will involve blood tests and checks on the patch.
Can I stop participating if I change my mind?
Absolutely. You are free to withdraw from the study at any time, for any reason, without affecting your medical care.
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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