Randomised, crossover bioequivalence clinical trial of edoxaban 60 mg tablets versus edoxaban 60 mg film-coated tablets, after a single oral dose administration to healthy volunteers under fasting conditions.
This research study is looking at a medicine called edoxaban, which helps thinning the blood. Specifically, we want to see if a slightly different version of the 60 mg tablet works just as well as the original 60 mg tablet. We call this a 'bioequivalence' study. Healthy adults will be given a single dose of each tablet on separate occasions, with a break in between. This helps us compare how the body takes in and uses each tablet. It's important to make sure any new tablet is as safe and effective as the one currently used, without making any recommendations about your own medication.
At a glance
What is this study about?
This study is about a particular medicine called edoxaban. Edoxaban is a type of medicine often used to help thin the blood, which can be important for various health reasons. Before any new or changed medicine can be given to patients, scientists need to make sure it works properly and safely. This particular study is comparing two versions of edoxaban 60 mg tablets. One is the current tablet, and the other is a new version that might look or be made slightly differently.
The main goal is to see if these two versions are "bioequivalent." This means checking if they deliver the same amount of medicine to your body at the same speed. It's a bit like making sure a new brand of a common food item tastes and performs exactly the same as the original. This is a standard and important step in developing medicines, and it ensures that if the new version is used, it will have the same effect as the old one.
This kind of study is called a "Phase I" study in drug development, which means it’s one of the first steps where a new medicine or new version of a medicine is tested in people, usually healthy volunteers. It's not about treating a specific illness, but rather understanding how the body handles the medicine itself.
Key takeaways
- Tests if a new edoxaban tablet works the same as the old one.
- Specifically for healthy adults aged 18 and over.
- Involves taking a single dose of each tablet while fasting.
- Blood samples are taken to compare how the body uses each tablet.
- Helps ensure future medicines are safe and effective.
- You can stop participating at any time.
Who may be eligible?
To take part in this study, you need to be a healthy adult. This means you generally feel well and don't have any major ongoing health problems.
Both men and women can join. You must be at least 18 years old; there's no upper age limit, meaning older adults who are otherwise healthy can also participate.
Because this is a study for healthy volunteers, people with existing ongoing medical conditions or who are taking regular medications (other than perhaps simple vitamins or birth control) would likely not be able to join. The team will carefully check your health to make sure it's safe for you to take part.
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 generally healthy with no major ongoing medical conditions?
- Are you 18 years old or older?
- Are you able to visit a clinic for study appointments?
- Are you comfortable with having blood samples taken occasionally?
What does participation involve?
If you decide to take part, you would be asked to visit the study clinic on a few separate occasions. On these visits, you’d receive a single dose of one of the edoxaban tablets. You wouldn't know if you're getting the current tablet or the new one, and everyone will receive both at different times during the study. You’d need to be fasting, meaning you wouldn’t have eaten for a certain number of hours before taking the medicine. After taking the tablet, the study team would take regular blood samples over a set period to see how the medicine is absorbed and leaves your body. You might stay at the clinic for several hours on these days. There will also be follow-up calls or visits to check on your well-being. The total length of your involvement, including all visits and follow-ups, would be explained to you before you agree to participate.
Potential risks and benefits
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Common questions
What does 'bioequivalence' mean?
It means we're checking if the new version of the tablet works in your body in the exact same way as the current version, delivering the same amount of medicine.
Will I know which tablet I am taking?
No, this is a 'blinded' study, meaning neither you nor the study team will know which tablet you're receiving on any given day. Everyone gets both versions at different times.
Why do I need to be 'fasting'?
Eating food can affect how your body absorbs medicine. Fasting helps us get a clear and accurate comparison of how each tablet works without food interfering.
Will I get paid for taking part?
Most studies for healthy volunteers offer some payment for your time and inconvenience. The study team will provide details on this.
How long will I be involved in the study?
The full duration will be explained by the study team, but it typically involves a few clinic visits spread over several weeks.
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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