An open label, randomized, four-period, four-sequence single dose, crossover trial in healthy volunteers to determine the relative bioavailability of Dimenhydrinate 50 mg (Test) administered with and without water vs. Vomex A 50 mg Lösung zum Einnehmen im Beutel (Reference 1) and Biodramina 50 mg Comprimidos (Reference 2)
This study is a Phase I trial, meaning it's an early-stage study looking at how certain medications behave in the human body. Researchers are comparing a new formulation of dimenhydrinate, a drug commonly used to prevent and treat nausea and vomiting, especially for motion sickness, with two existing brands. They want to see how these different versions are absorbed and used by the body when taken with or without water. This is crucial for ensuring that new medications, or new versions of existing ones, are as effective and safe as possible. The study involves healthy volunteers and is designed to gather important information before these medications might be used more widely.
At a glance
What is this study about?
Imagine you're going on a journey and you sometimes feel queasy or sick. There are medicines that can help with this, often called anti-sickness tablets. This short study is looking at one of these medicines called dimenhydrinate, which is used to help with feeling sick or actually being sick, especially when it's due to things like travel sickness.
In this study, researchers are comparing a new version of dimenhydrinate (called the 'Test' medicine) with two other existing brands of the same type of medicine. They want to find out if the new version is absorbed by the body in the same way as the established brands. This is important because it tells us if the new version will work just as well. They're also checking if taking the medicine with or without water makes a difference.
Because this is an early study, it's called a 'Phase I' trial. This means it's done with healthy volunteers, not people who are feeling sick. The main goal is to understand how the medicine behaves in the body – how quickly it gets into your system and how long it stays there. This information helps doctors and scientists make sure any new medicines, or new ways of taking old medicines, are effective and safe for future use.
Key takeaways
- This study compares how different versions of an anti-sickness medicine are absorbed.
- It's a very early-stage study involving healthy volunteers.
- The primary goal is to understand how the medicine behaves in the body.
- Participation involves taking single doses of different medicines over time.
- It helps ensure new medicines are effective and safe for public use.
Who may be eligible?
To take part in this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults can also participate.
This study is open to both men and women. The most important thing is that you are generally healthy. This means you shouldn't have any major ongoing health problems or be taking medications that might interfere with the study drugs.
Detailed health checks will be carried out before you can officially join the study to make sure it's safe for you to participate.
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?
- Are you able to commit to several clinic visits?
- Are you comfortable with blood tests?
What does participation involve?
If you decide to take part, you'll be involved in what's called a 'crossover' study. This means you'll receive each of the different medication versions being tested at different times, separated by a break. You'll switch between the 'Test' medicine, one reference medicine, and then another reference medicine over four separate periods.
During each period, you'll be given a single dose of the medication. Researchers will then closely monitor you, likely taking blood samples at specific times to see how the medication is absorbed and processed by your body. You might have to visit the clinic multiple times for these assessments. The total time you'd spend involved in the study, including all visits and follow-up, would be made clear before you consent to participate.
Potential risks and benefits
Locations (1)
- —UnverifiedBulgaria
Common questions
What is dimenhydrinate normally used for?
It's typically used to prevent and treat nausea and vomiting, especially for things like travel sickness.
Why are healthy volunteers needed for this study?
Because it's an early-stage study, it's important to see how the medicines behave in generally healthy people before testing them in those who are unwell.
What does a 'crossover' study mean?
It means you'll get each of the different medications being tested at different times, allowing researchers to compare them within the same person.
Will I be paid for taking part?
Most Phase I studies offer compensation for your time, effort, and inconvenience.
Can I stop participating if I change my mind?
Yes, you are free to withdraw from the study at any point without needing a reason.
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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