Randomised, crossover bioequivalence clinical trial of memantine 20 mg capsules versus memantine 20 mg film-coated tablets, after a single oral dose administration to healthy volunteers under fasting conditions.
This study is a bioequivalence trial, which means it's comparing two different versions of the same medicine. The medicine is memantine, which is used to treat Alzheimer's disease. Researchers want to see if memantine given as a 20mg capsule works in the body in the same way as memantine given as a 20mg film-coated tablet. Healthy adult volunteers will take a single dose of each type of medicine on different days after not eating for a while (fasting). This helps make sure the results are accurate. Understanding if these different forms of the medicine act alike is important for doctors and patients.
At a glance
What is this study about?
This study is looking at an important medicine called memantine, which is used to help people with Alzheimer's disease. Medicines are often made in different forms, like capsules or tablets, but it's really important to make sure all these different forms work in the body in the same way. This is what a 'bioequivalence' study aims to find out.
Think of it like different brands of a common painkiller; even though they look different, you still expect them to have the same effect. For memantine, researchers want to see if the 20mg capsule and the 20mg film-coated tablet deliver the medicine to your body in the same amount and at the same speed after you take them.
By carefully comparing these two forms of memantine in healthy volunteers, scientists can confirm that if a doctor prescribes memantine, it will work consistently, regardless of whether it's given as a capsule or a tablet. This helps ensure patients always get the correct and effective amount of their medication.
Key takeaways
- This study compares memantine capsules and tablets for Alzheimer's disease.
- It checks if both forms work the same way in the body.
- Healthy adult volunteers are needed for this research.
- Participants will fast and have blood samples taken.
- It helps ensure consistent medicine effectiveness for patients.
Who may be eligible?
This study is looking for healthy volunteers. You'll need to be an adult, aged 18 years or older, to take part.
Since this study involves taking medication, there will be a thorough check-up to make sure you are in good general health and that it's safe for you to participate.
Both men and women are welcome to join this study.
- Are you 18 years old or older?
- Are you generally healthy?
- Are you comfortable having regular blood samples taken?
- Are you able to follow specific instructions, like fasting?
- Are you willing to commit to the study schedule?
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 would receive a single dose of one type of memantine (either the capsule or the tablet) on a specific day. After a break, you would then receive the other type of memantine. This 'crossover' approach allows researchers to compare the two medicines in the same person.
Before you start, you'll have a health check-up. You'll need to go without food (fast) for a certain period before taking the medication. After you take the dose, your blood will be drawn several times over a set period to measure how the medicine moves through your body. The total time you'd be involved in the study, including all visits and follow-ups, would be explained in detail by the study team.
Potential risks and benefits
Locations (1)
- —Spain
Common questions
What is memantine and why is it used?
Memantine is a medicine prescribed to help manage the symptoms of Alzheimer's disease.
What does 'bioequivalence' mean?
It means the study is checking if two different forms of the same medicine work in the body in exactly the same way.
Do I need to have Alzheimer's disease to be in this study?
No, this study is looking for healthy volunteers, not people with Alzheimer's, to ensure clear results.
Will I take both a capsule and a tablet?
Yes, you will take both forms of the medicine at different times, which helps compare them effectively.
Will I get paid for taking part?
While not always guaranteed, many healthy volunteer studies offer some payment for your time and inconvenience. The study team will provide full details.
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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