Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Randomized, open-label, single dose, two-period, two-treatment, cross-over bioequivalence study comparing test product Rivaroxaban/Acetylsalicylic acid, tablet, 2.5 mg/50 mg (given as two tablets) to reference product Xarelto 2.5 mg film-coated tablets (given as two tablets) and Aspirin® N 100 mg tablet in healthy male and female subjects under fasting conditions.

This research study is looking at a new combination tablet that contains two medicines: rivaroxaban and aspirin. These are commonly used to prevent blood clots. We want to check if this new combination tablet acts in the body in the same way as taking the two medicines separately (Xarelto and Aspirin® N). This type of study is called a 'bioequivalence' study. It helps us understand if different versions of a medicine deliver the same amount of the active ingredients to your bloodstream. The study involves healthy adult volunteers and will be a single-dose comparison. It's a key step in developing new medicines, ensuring they work effectively and safely.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Adamed Pharma S.A.

Enrolment target

Start

13 Jun 2024

not applicable (submitted trial is a bioequivalence in healthy subjects)

What is this study about?

You might be wondering what this study is all about. It's a research study looking at a new tablet that combines two well-known medications: rivaroxaban and aspirin. These medicines are often prescribed to help prevent blood clots in people who are at risk. For example, after certain surgeries or for people with specific heart conditions.

The main goal of this study is to see if this new combined tablet works in your body in the same way as taking the two medicines separately. This is very important because it helps us understand if the new combined tablet delivers the same amount of each medicine into your bloodstream, and if it does so at the same speed. If it does, doctors can be confident that the new combination will have the same effects as the separate medicines.

This type of study is called a 'bioequivalence' study. It's a standard and necessary step in the development of new medicines, even when they contain ingredients that are already well-known. It isn't about treating an illness, but rather about gathering important information to make sure new drug forms are effective and safe for future patients.

Key takeaways

Compares a new combination pill to existing separate medicines.
Aims to check if they work the same way in the body.
Involves healthy adult volunteers.
Participation includes two visits with medicine doses and blood tests.
You won't be treated for an illness; it's for medical research.
You can stop participating at any time.

Who may be eligible?

This study is looking for healthy adults. You need to be at least 18 years old, and there is no upper age limit, as long as you are generally healthy.

Both men and women can take part in this study. The most important thing is that you are in good health. This means you don't have any major ongoing medical conditions and don't take regular medication that could interfere with the study drugs.

The research team will carry out some checks to make sure you're healthy enough to take part. This will involve talking about your medical history and having some basic health tests.

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 not have any major ongoing medical conditions?
Are you able to follow specific study instructions, like fasting?
Are you able to attend appointments at the study site?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive a single dose of the study medicine on two separate occasions. This means you'll typically visit the study site for a short stay (e.g., a day or two) twice, with a break in between. During these visits, you'll be given either the new combination tablet or the separate existing medicines, and we'll take blood samples at specific times to measure how the medicine is absorbed by your body. You'll need to follow specific instructions, such as fasting (not eating) before your dose. The total duration of your involvement, including all visits and follow-up, will be relatively short, likely a few weeks in total.

Potential risks and benefits

Participating in research studies like this helps advance medical knowledge and can lead to new treatment options for others in the future. However, as with any medicine, there is always a chance of side effects from the study drugs, although they are generally well-known and mild given these are existing medications. You will be closely monitored by medical staff throughout the study. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care outside of the study.

Locations (1)

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

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Unverified
Czechia

Common questions

What is a bioequivalence study?

It's a study that checks if a new version of a medicine (or a combination) acts the same way in the body as an existing one, by measuring how much of the drug gets into your bloodstream and how quickly.

Will this study help my health directly?

No, this study is for research and development, not to treat any illnesses. It helps create new medicines for future patients, but won't provide direct health benefits to participants.

Do I need to stop eating before taking the medicine?

Yes, for this study, you will be asked not to eat for a certain period before taking the medicine. This is called 'fasting' and helps ensure consistent results.

How many times will I visit the study site?

You will typically have two separate visits where you receive a dose of the medicine and have blood samples taken. There will be a 'washout' period in between.

Will I know which medicine I'm getting?

Yes, this is an 'open-label' study, which means both you and the study team will know whether you are receiving the new combination tablet or the separate existing medicines at each visit.