Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

The pivotal bioequivalence study comparing the test product to the reference product, which belongs to the group of medicines used in treatment and prevention of Influenza.

This study is comparing a new flu medicine (the 'test product') with an existing one (the 'reference product') to check if they are the same. This is called a 'bioequivalence study'. It's an early phase of research (Phase I), which means it's about understanding how the new medicine works in the body. Researchers will be looking at things like how much of the medicine gets into the bloodstream and how quickly. This step is important to make sure that the new medicine will be just as safe and effective as the original one for treating and preventing flu. The study is open to adults aged 18 and over, and both men and women can take part. It helps ensure new medicines are reliable.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Adamed Pharma S.A.

Enrolment target

Start

23 Oct 2024

influenza

What is this study about?

Imagine you have a well-known flu medicine that helps millions of people. Now, a company has made a new version of that medicine. Before this new version can be used widely, doctors and scientists need to be very sure it works exactly the same way as the original. This study, called a 'bioequivalence study', is designed to do just that.

The main goal is to compare the new medicine (the 'test product') with the original one (the 'reference product'). Researchers will carefully measure how the body absorbs, uses, and gets rid of both medicines. They want to see if the new version behaves in the body in the same way as the established one. This means ensuring the same amount of medicine gets into your system at the same speed and stays there for the same length of time, ultimately providing the same benefits for treating and preventing flu.

This is a very early stage of research, sometimes called 'Phase I'. At this stage, studies often involve healthy volunteers rather than people who are ill. It helps gather important information about how a medicine works in the body before it's tested in larger groups of people with the actual condition. This careful process is a vital part of bringing new, reliable medications to patients in the UK.

Key takeaways

This study compares a new flu medicine with an existing one.
It's an early-stage study (Phase I) usually involving healthy adults.
The goal is to ensure the new medicine works the same way.
Open to adults aged 18 and over, both men and women.
Participation helps bring new, reliable medicines to patients.

Who may be eligible?

The study is looking for healthy adult volunteers to take part. This means you must be at least 18 years old or older. There is no upper age limit, so adults of any age can be considered if they meet other criteria.

Both men and women are welcome to participate in this study. The researchers want to get a broad understanding of how the medicine works, so they need a diverse group of participants.

Because this is an early study to see how a medicine works in the body, participants will likely need to be generally healthy. Specific health checks will be done by the study team 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 18 years old or older?
Are you generally healthy?
Are you able to commit to several study visits?
Are you comfortable with regular blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive doses of both the new flu medicine and the existing one, usually at different times. Researchers would then take regular blood samples to measure how much of the medicine is in your body over a certain period. You would likely need to visit the study clinic multiple times, and some visits might involve staying for several hours or even overnight. You might also have other checks like blood pressure or heart rate monitoring. The total length of your involvement would depend on the study's design, but typically for this type of research, it could involve a few study periods spread over several weeks.

Potential risks and benefits

Taking part could offer the benefit of contributing to medical science and helping to ensure that new medicines are safe and effective for others in the future. As with any medicine, there's always a chance of side effects, even in healthy volunteers. The study team will carefully explain any known or potential risks associated with the medicines being tested. You will be closely monitored by medical professionals throughout the study. Remember, your participation is voluntary, and you have the right to 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
Czechia

Common questions

What does 'bioequivalence' mean?

It means the study is checking if a new version of a medicine works exactly the same way in the body as an existing, approved version.

What is 'Phase I' research?

Phase I is the earliest stage of human testing for a new medicine. It usually involves a small number of healthy volunteers to see how the medicine is processed by the body and if it's safe.

Will I get the actual flu medicine, or a dummy pill?

In this study, you will likely receive both the new flu medicine and the existing flu medicine. This is so researchers can compare them directly, not a dummy pill.

Do I need to have the flu to join this study?

No, this study is a 'Phase I bioequivalence' trial, which typically involves healthy volunteers, not people who currently have the flu.

What would a study visit involve?

A study visit would typically involve taking the study medication, having blood samples taken over several hours, and possibly other health checks like blood pressure.