Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence clinical trial of two formulations of edoxaban.

This research study is about a medicine called edoxaban, which is often used to prevent blood clots. Researchers are comparing two different versions, or 'formulations,' of this medicine. The main goal is to check if these two versions behave in the same way once they are inside the body. This is a common step when developing new medicines, especially when a generic version might be introduced. They are looking for healthy people to take part. By understanding how the medicine is absorbed and used by the body, doctors can be confident that patients receive the right treatment, no matter which version of the medicine they take. This type of study helps ensure the safety and effectiveness of new medicines for future patients.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Normon S.A.

Enrolment target

Start

14 May 2024

Healthy volunteers

What is this study about?

Imagine you have a headache and you take a paracetamol. If a different company makes their own paracetamol, you'd want to be sure it works just as well as the one you usually take, right? This study is quite similar. It's looking at a medicine called edoxaban, which is used to help prevent blood clots.

Researchers want to compare two different versions of edoxaban to see if they both act the same way in the body. This is really important to make sure that if a new version of a medicine becomes available, it will work just as effectively and safely as the original. They're trying to find out if both versions deliver the same amount of the medicine into your bloodstream at the same speed.

This kind of study is a vital step in making sure that all medicines available to the public are reliable and do what they're supposed to do. It helps doctors and pharmacists know that they are giving you a medicine that will work consistently, regardless of which company has made it. By taking part, you'd be helping to make sure future patients get effective treatment.

Key takeaways

This study compares two versions of an anti-clotting medicine called edoxaban.
It's for healthy adults to check if both versions work the same way in the body.
Participation involves taking the medicine and having regular blood tests.
Your involvement helps ensure the safety and effectiveness of new medicines.
You can withdraw from the study at any time if you change your mind.

Who may be eligible?

This study is looking for healthy adults to take part. You must be at least 18 years old.

Both men and women are welcome to participate. There isn't an upper age limit mentioned, but generally, studies like this look for people who are in good general health.

Because this study is about checking how a medicine works in a healthy person, you shouldn't have any major ongoing health conditions. If you're on any regular medication, it's really important to discuss this with the study team.

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?
Are you comfortable having blood samples taken?
Are you able to attend clinic visits as required?
Are you not currently pregnant or breastfeeding (if applicable)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given doses of both versions of the edoxaban medicine at different times, as directed by the study team. You wouldn't be taking both at once, and there would be breaks between when you take each version.

During these periods, you would likely need to visit the study clinic for appointments. These visits would involve having blood samples taken. The blood tests help the researchers measure how much of the medicine is in your body and how it's being handled by your system.

The study would involve careful monitoring by the medical team. The total duration of the study, including all visits and follow-up, would be explained to you in detail before you agree to take part.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is contributing to medical science by helping to ensure new medicines are safe and effective for future patients. You might also receive free health checks during your participation. Potential risks could include side effects from the investigational medicine, although these studies are usually carefully designed to minimise risks. There's also the discomfort of blood draws. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What is edoxaban used for?

Edoxaban is a medicine often prescribed to help prevent blood clots in people who are at risk, for example, after certain surgeries or if they have a heart condition called atrial fibrillation.

What does 'bioequivalence' mean?

Bioequivalence means that two different versions of the same medicine act in the same way in your body. This ensures they are just as safe and effective as each other.

Will I receive the actual treatment for a health condition?

No, this study is for healthy volunteers to see how the medicine works in the body, not to treat a specific illness you might have.

Do I have to pay to join the study?

No, you will not have to pay to take part in this study. All study-related care and medication are provided free of charge, and you may even be compensated for your time and travel.

What if I feel unwell during the study?

If you feel unwell at any point during the study, you should tell the study team immediately. They will monitor your health closely.