Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A single-dose, randomized, two-period, two-sequence, crossover pilot bioequivalence study on formulations containing rivaroxaban and acetylsalicylic acid in healthy volunteers under fasting conditions.

This study is a small, early-stage trial looking into how a new combined medicine works in the body. It contains two well-known medications: rivaroxaban, which helps prevent blood clots, and acetylsalicylic acid (often called aspirin), which also helps thin the blood. Researchers want to compare a new type of combined pill with taking the two medicines separately. They will check if the new combined pill delivers the same amount of each medicine into the bloodstream. This is important to make sure the combined pill would be just as effective and safe as taking each medication on its own. The study involves healthy adult volunteers and will help us understand more about how these medicines are absorbed and used by the body.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Cepha s.r.o., Pozlab Sp. z o.o.

Enrolment target

Start

05 Feb 2024

increased blood clotting

What is this study about?

Imagine you sometimes need to take two different medicines at the same time. This study is exploring a new idea: combining two commonly used drugs, rivaroxaban and acetylsalicylic acid (aspirin), into a single pill. Both of these medicines are important for people who need to reduce their risk of blood clots. Rivaroxaban is a powerful medicine that helps stop blood from clotting too easily, and aspirin is a milder blood thinner many people take for heart health.

The main goal of this particular study isn't to see if the medicines treat a condition, but rather to make sure a new combined pill works in the same way as taking the two medicines separately. This is called a 'bioequivalence' study. It means researchers want to check if the new combined tablet delivers the same amount of each medicine into your body as taking the individual tablets would.

This is a vital first step before any new combined medicine can be considered for wider use. By checking this in healthy volunteers, scientists can be sure that if this combined pill were to be developed further, it would give patients the right amount of each medicine. This helps ensure it would be as safe and effective as taking the separate pills, but potentially more convenient.

Key takeaways

This study is testing a new combined medicine containing two blood thinners.
It aims to see if the combined pill works the same way as taking the medicines separately.
Only healthy adults are able to take part.
Participation involves taking medicines and giving blood samples.
This research helps make sure new medicines are safe and effective.
You can stop participating at any time.

Who may be eligible?

This study is looking for healthy adults to take part. To be eligible, you need to be at least 18 years old. There's no upper age limit mentioned, so older adults could also be considered.

Both men and women are welcome to participate in this research. The most important thing is that you are generally in good health and don't have any major medical conditions that might affect how the medication works in your body. Specific details about your health will be checked by the study doctors.

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 at least 18 years old?
Are you generally in good health?
Are you able to visit a clinic for study appointments?
Are you comfortable with giving blood samples?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to visit the study clinic multiple times. You'll switch between taking the new combined medicine and taking the two separate medicines, with a break in between. This is called a 'crossover' design.

During your visits, you'll provide blood samples so researchers can measure how much of each medicine is in your system over time. You'll be closely monitored for any side effects. All medication will be provided by the study. The total duration of your participation will be explained to you in detail.

Potential risks and benefits

The potential benefits of taking part include contributing to medical science and helping to develop potentially more convenient medication for patients in the future. As with any medication, there are potential risks, such as side effects from the medicines. These medicines are known to increase the risk of bleeding. All potential risks will be fully explained before you agree to take part. You have the right to withdraw from the study at any time without giving a reason, and it will not affect your 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
Czechia

Common questions

What does 'healthy volunteers' mean?

It means people who are generally well and don't have any serious health problems that might affect the study results.

What are rivaroxaban and acetylsalicylic acid (aspirin) used for?

Both medicines help to prevent blood clots. Rivaroxaban is a stronger clot-preventer, and aspirin is a milder blood thinner.

What is a 'bioequivalence' study?

It's a study that checks if a new version of a medicine (like a combined pill) works the same way in the body as an older version or separate pills.

Will I get better if I join this study?

This study isn't designed to treat an illness, but to understand how medicines work in healthy people. You won't directly get better from taking part.

Can I take other medicines during the study?

You'll need to tell the study team about all medicines you are taking, including over-the-counter ones, as some might affect the study drugs or your safety.