AuthorisedHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Randomised, crossover bioequivalence clinical trial of edoxaban 60 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 compares a new version of a medicine called edoxaban with the original to see if they are absorbed into the body in the same way. Edoxaban is a 'blood thinner' used to prevent blood clots. However, this study isn't about treating blood clots; it's about checking the new medicine itself. Healthy volunteers will take a single dose of the new edoxaban tablet while fasting. Researchers will then measure how much of the medicine gets into their bloodstream and how long it stays there. The aim is to make sure the new version is just as safe and effective as the original.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Biohorm S.L.

Enrolment target

Start

22 Dec 2022

Edoxaban is used as antithrombotic agents, but it is a bioequivalence trial and the study population is healthy volunteers

What is this study about?

This clinical trial is looking at a medicine called edoxaban, which is often used to help prevent blood clots in people at risk. However, this study isn't about treating or preventing blood clots directly in patients. Instead, it's a special type of study called a 'bioequivalence trial'. This means the researchers want to see if a new version of the edoxaban tablet works in exactly the same way as the original, established version.

Imagine you have a well-known brand of a painkiller, and a company makes a new generic version. Before that new generic version can be sold, studies like this are done to prove it's just as good. For edoxaban, this study will check if the body absorbs the new tablet in the same amount and at the same speed as the original. This is important to ensure that if this new version becomes available, it will have the same benefits and risks as the original medicine.

To do this, healthy volunteers will take a single dose of the edoxaban tablet on an empty stomach. The researchers will then carefully measure the levels of the medicine in their blood over time. This helps them understand how the new tablet behaves inside the body. If the new tablet is "bioequivalent" to the original, it means it's processed by the body in the same way, making it a reliable alternative.

Key takeaways

This study compares a new version of the blood-thinner edoxaban to an existing one.
It aims to ensure both versions are absorbed by the body in the same way.
Only healthy adults aged 18 and over can participate.
You will take a single dose of edoxaban while fasting, followed by blood tests.
Participation helps pharmaceutical development but offers no direct health benefit to you.
You can stop participating at any time.

Who may be eligible?

This study is looking for healthy adults to take part. You must be at least 18 years old to be considered. The study is open to both men and women.

Because this is a trial for healthy volunteers, you will need to be in good general health. They will likely check your medical history and do some health checks to make sure you are suitable and that it's safe for you to take part.

It's important to remember that this study is not for people who are currently using edoxaban for a medical condition or who have conditions that affect how their body deals with medicines.

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 with no serious medical conditions?
Are you able to follow study instructions, including fasting?
Are you comfortable with having blood samples taken regularly?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will likely need to visit the study clinic several times. On at least one of these visits, you will be given a single 60 mg edoxaban tablet to take by mouth after you've fasted (which means not eating for a certain period before taking the medicine). After you take the medicine, you will have several blood samples taken over a set period to measure the medicine levels in your body. There will also be health checks, like blood pressure and heart rate measurements, throughout your time in the study. Because it's a 'crossover' study, you might take the medicine more than once, with a break in between, possibly even taking a different version of the medicine some time later. The total duration of your participation will depend on the study design, but generally, bioequivalence studies involve a few clinic visits and a follow-up check.

Potential risks and benefits

Taking part in a study like this helps advance medical science by ensuring new medicines are safe and effective. While there isn't a direct health benefit to you as a healthy volunteer, you might receive some payment for your time and travel. Potential risks include discomfort from blood draws, very rare allergic reactions to the medicine, or side effects from edoxaban, although healthy volunteers are carefully screened. You can withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Spain

Common questions

What is edoxaban and why is it used?

Edoxaban is a medicine that helps to thin the blood, often used to prevent harmful blood clots in people who are at risk, for example, after certain surgeries or with specific heart conditions.

Am I a 'patient' in this trial?

No, this study is for 'healthy volunteers'. It's not designed to treat a medical condition you might have, but rather to test how a new medicine works in people who are generally well.

What does 'fasting conditions' mean?

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. This helps ensure the medicine is absorbed consistently.

Will I receive any money for taking part?

Many clinical trials for healthy volunteers offer some payment to compensate for your time, travel, and any inconvenience. This will be clearly explained before you agree to participate.

Why do they need healthy people for this study?

Using healthy volunteers allows researchers to understand how the medicine works in a typical, healthy body without other health conditions or medicines complicating the results.