Bioequivalence of Cinnarizine/Dimenhydrinate 20 mg/40 mg Tablets in Healthy Participants Under Fed Conditions.
This study is called a bioequivalence study. It's designed to see if a new combination tablet, containing two medicines called cinnarizine and dimenhydrinate (used for dizziness and nausea), is absorbed by the body in the same way as an already approved version. This is important to ensure that patients will get the same amount of medicine, and therefore, the same effect, from the new tablet as they would from the older one. Healthy adult volunteers will be asked to take the tablets after eating, and researchers will measure how the medicine levels change in their blood over time. This type of study helps pharmaceutical companies develop new medications or new versions of existing ones, making sure they are just as effective and safe.
At a glance
What is this study about?
This study is a type of research called a 'bioequivalence' study. Imagine you have a familiar brand of a painkiller, and then a new, similar version comes out. A bioequivalence study checks if the new version delivers the medicine to your body in the exact same way as the original. In this study, researchers are looking at tablets that combine two medicines: cinnarizine and dimenhydrinate. These are commonly used together to help with symptoms like dizziness and nausea, often experienced with motion sickness or certain inner ear problems.
Healthy adults will take the tablets after having a meal. Scientists will then take blood samples at different times. They will measure how much of the medicines get into the bloodstream and how quickly. This helps them understand how the body absorbs and processes the medicines from the new tablet compared to an established one.
This kind of study is really important for ensuring the quality and effectiveness of medicines. It helps confirm that when new versions of drugs are made available, they will work just as expected and be as safe as the original. It's not about testing whether the medicines themselves work – that's already known – but rather ensuring that the new tablet delivers the medicines correctly to your body.
Key takeaways
- This study checks if a new version of a dizziness/nausea tablet works like an old one.
- It's for healthy adults, aged 18 and over, both men and women.
- Participants take the tablets with food and have blood samples taken.
- It helps ensure new medicines are safe and effective for everyone.
- This is NOT a study to treat a medical condition.
- You can stop participating at any time.
Who may be eligible?
This study is looking for healthy adults to take part. This means you should generally be in good health and not have any ongoing medical conditions that require regular medication or treatment. The aim is to understand how the medicine behaves in a typical, healthy body.
You need to be at least 18 years old to join this study – there's no upper age limit, as long as you meet the other health criteria. Both men and women are welcome to participate. The health checks during the screening process will make sure that taking part is safe for you.
More specific details about what counts as 'healthy' will be discussed by the study team. For instance, they might be looking for people who don't smoke, or who are within a certain weight range, or who don't have certain allergies. These details ensure that the study results are as clear and reliable as possible.
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 in good health?
- Do you have no specific ongoing medical conditions?
- Are you willing to take study medication and have blood samples taken?
- Are you able to follow study instructions, including eating specific meals?
What does participation involve?
If you decide to take part, you would first go through a screening process, which involves a health check, blood tests, and a review of your medical history to ensure you are healthy and suitable for the study. If you qualify, you will stay at the study clinic for a period, where you will be given the study medication (the cinnarizine/dimenhydrinate tablets) after a meal.
After taking the tablets, nurses or doctors will take regular blood samples from you over several hours. These samples help them measure how the medicine levels change in your blood. There might be a few study visits or a stay at the clinic across a couple of periods, often separated by a short break.
The total amount of time you would be involved from your first visit to your last follow-up will be explained by the study team. Throughout the study, your health will be regularly monitored.
Potential risks and benefits
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Common questions
What exactly are cinnarizine and dimenhydrinate?
They are two medicines often combined to treat symptoms like dizziness, spinning sensations (vertigo), and nausea, commonly associated with motion sickness or inner ear problems.
Why do I need to take the tablets with food?
Taking medicine with food can sometimes change how it's absorbed by your body. This study specifically wants to see how the tablets work under 'fed conditions', meaning after you've eaten a meal.
Will I receive treatment for a medical condition?
No, this is not a treatment study. It's a bioequivalence study for healthy people to see how the medicine is absorbed, not to treat any illness you might have.
How many times will I have blood drawn?
Blood will be drawn multiple times over a period after you take the medication. The exact number and timing will be explained in detail by the study team.
Will I be paid for participating?
Many clinical studies offer compensation for time, travel, and inconvenience. You should ask the study team about any potential payment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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