An open label, randomized, crossover, two-period, two-sequence, multiple dose study to assess the relative bioavailability of Rotigotine 4.5 mg (2 mg/24 hrs) transdermal patch (Test Product) compared to Neupro® 2 mg/24 h Transdermal Patch (Reference product) in 48 healthy adult volunteers under fasting conditions.
Doctors are testing a new skin patch that contains the medicine rotigotine. This medicine is used to treat Parkinson's disease. The study aims to compare how the new patch, called the 'Test Product', delivers rotigotine into the body compared to the well-known 'Neupro®' patch. This is purely a comparison study, not a test of the medicine itself for treating Parkinson's. We want to make sure the body absorbs the medicine from the new patch in a similar way to the established patch. 48 healthy adults will wear both types of patches at different times to help us understand this. It's focused on understanding how the medicine gets into your system, not on treating an illness.
At a glance
What is this study about?
This study is designed to understand how a new skin patch delivers medicine into your body. The medicine is called rotigotine, which is used for conditions like Parkinson's disease. The official name for this type of research is a 'bioequivalence study'. What that really means is we're comparing two versions of the same medicine – a new patch and an existing, approved patch – to see if your body absorbs the medicine from them in a similar way.
Imagine you have two different brands of a painkiller. Even though they both have the same active ingredient, this study helps us check if your body gets the same amount of medicine from one brand as it does from the other. For this particular study, we're testing the rotigotine patches. We want to be sure that the new patch works just as well at getting the medicine into your bloodstream as the existing Neupro® patch.
This kind of study is really important because it helps ensure that new medicines, even if they're slightly different versions of existing ones, are just as effective and safe. It's a key step before a new patch could become more widely available in the future. By taking part, you'd be helping doctors gather vital information about how medicines are absorbed.
Key takeaways
- Compares a new rotigotine patch with an existing one.
- Studies how medicine is absorbed by the body.
- Involves 48 healthy adult volunteers.
- Requires multiple visits and blood samples.
- Participation helps advance medical knowledge.
- You can withdraw at any time.
Who may be eligible?
To join this study, you need to be a healthy adult aged 18 or over. This study is specifically for healthy volunteers, meaning you should not have any ongoing medical conditions that would affect how your body processes medication.
Both men and women can take part. The study doesn't have an upper age limit, as long as you are generally healthy.
Because this study is about how your body absorbs medication, you'll need to be generally well and not taking other medicines that could interfere with the results. More detailed checks would be done by the study team to confirm you are suitable.
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 serious medical conditions?
- Are you able to attend clinic visits as required?
- Are you comfortable with having blood samples taken?
- Are you capable of understanding and following study instructions?
What does participation involve?
If you decide to take part, you'll be one of 48 healthy adults in the study. This is a 'crossover' study, which means you'll try both types of patches. You'll wear one type of patch for a set period, then after a break, you'll wear the other type of patch.
During the study, you'll have several visits to the clinic. You'll need to wear the patches, and the research team will take blood samples to measure how much rotigotine is in your system. This helps them understand how the medicine is being absorbed. You'll also be asked to follow specific instructions, such as fasting before some visits, which means not eating for a certain period.
The total amount of time you're actively involved in the study, from your first visit to your last follow-up, will be explained in detail by the study team. They will also tell you about any specific foods or activities you might need to avoid during the study periods.
Potential risks and benefits
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Common questions
Why are healthy people needed for this study?
Healthy people help us understand how the medicine works in a typical body without effects from other health conditions.
What is rotigotine used for?
Rotigotine is a medicine used to treat conditions like Parkinson's disease. This study is about how it's absorbed, not treating these conditions.
Will this patch be available for everyone soon?
This study is an early step. If successful, it helps get closer to potentially making the new patch more widely available in the future.
Do I need to be on a special diet?
You'll likely need to fast (not eat) before certain visits. Specific diet instructions will be provided by the study team.
Will I get paid for taking part?
Payment for participation in research studies varies. This will be discussed with you by the study team if it applies.
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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