Randomised, bioequivalence clinical trial of rasagiline 1 mg capsules vs rasagiline 1 mg tablets, after a single oral dose administration to healthy volunteers under fasting conditions in crossover replicated design.
This research is looking at two different forms of a medicine called rasagiline, which is used for Parkinson's disease. One form is a capsule, and the other is a tablet. The main goal is to see if the body absorbs and uses the capsule medication in the exact same way as the tablet version. To do this, healthy volunteers will take a single dose of each medicine on separate occasions. This helps researchers understand if the new capsule form will be just as effective as the existing tablet. It’s part of ensuring new medicines or new versions of medicines work as intended.
At a glance
What is this study about?
This study is a type of research called a "bioequivalence" study. In simple terms, this means the researchers want to find out if two different versions of the same medicine work in exactly the same way in the body. In this case, they are comparing a new capsule form of a medicine called rasagiline with the rasagiline tablet that is already available. Rasagiline is a medicine used to help people with Parkinson's disease.
The idea is to make sure that if a new capsule version of a medicine is introduced, it will have the same effect as the tablet currently used. This is important because consistency ensures that patients get the correct and expected amount of medication into their system, no matter which form they take. It's a standard step in the process of developing and approving new ways to deliver existing medications.
So, this study isn't about finding a new cure for Parkinson's disease. Instead, it's about making sure that if a patient needs to take rasagiline, they can be confident that a capsule form would work just as well as the tablet form they might already be familiar with. It helps ensure quality and effectiveness for patients.
Key takeaways
- This study compares a capsule and a tablet of the same medicine, rasagiline, used for Parkinson's disease.
- It's checking if both forms of the medicine are absorbed equally by the body.
- The study needs healthy volunteers, 18 years or older, both men and women.
- You'll take single doses of each medicine on different days and have blood samples taken.
- It helps ensure new medicine forms are just as effective for patients.
Who may be eligible?
To be able to join this study, you need to be a healthy adult aged 18 or older. The study is open to both men and women.
Being "healthy" usually means you don't have any major ongoing medical conditions, you're not taking certain regular medications, and you have no history of significant health problems that might affect how your body responds to the study medicine. More detailed health checks will be explained by the study team.
The study also needs volunteers to be able to follow all the study instructions, including attending appointments and taking the medicine as directed.
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 aged 18 years or older?
- Do you consider yourself to be generally healthy?
- Are you able to follow all study instructions and attend appointments?
- Are you comfortable with giving blood samples?
- Are you not currently pregnant or breastfeeding (if applicable)?
What does participation involve?
If you decide to take part in this study, you'll be asked to visit the study clinic several times. During these visits, you'll take a single dose of either the rasagiline capsule or the rasagiline tablet. You'll switch between the capsule and tablet forms, taking each on different visits after a break period in between. You'll usually be asked to take the medicine after not eating for a certain period (this is called "fasting").
After you take each dose, the study team will take blood samples regularly over a period to check how your body absorbs and processes the medicine. You might also have other check-ups, like blood pressure or heart rate measurements, to ensure your safety. The total time you'll be involved with the study, from your first visit to your last, will be explained in detail by the study team. You'll be given clear instructions at every step.
Potential risks and benefits
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Common questions
What is rasagiline used for?
Rasagiline is a medicine used to help people who have Parkinson's disease.
Why are you doing this study?
We want to check if a new capsule form of rasagiline works exactly the same way in the body as the tablet form that is already available.
Do I have to have Parkinson's disease to join?
No, this study is looking for healthy volunteers, not people with Parkinson's disease.
What does 'fasting' mean in this study?
Fasting means you will be asked not to eat or drink anything (except plain water) for a certain number of hours before taking the study medicine.
Will I get paid for taking part?
Details about any payment or compensation for your time and travel will be discussed by the study team if you are suitable to participate.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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