Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Randomized, Four-Way Change-over Study to Evaluate the Effect of Moderate Heat, Occlusion, and Moderate Exercise on the Pharmacokinetics and Tolerability of the Esflurbiprofen Topical System in Healthy Volunteers

This research study is trying to understand how a special skin patch, which contains a medicine called esflurbiprofen, works in the body. Specifically, we're interested in whether everyday activities or conditions, like being in a warm environment, covering the patch with a dressing, or doing some gentle exercise, affect how much of the medicine gets absorbed. This type of study helps us learn about the medicine's pathway in the body, but it's not designed to treat any medical conditions. We are inviting healthy adult volunteers to participate, and they will receive the patch under different conditions during the study.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Teikoku Seiyaku Co. Ltd.

Enrolment target

Start

18 Dec 2024

bioavailability trial with healthy volunteers therapeutical indication not studied

What is this study about?

This study is about a new way of giving medicine through a skin patch, specifically one that contains a drug called esflurbiprofen. It's a bit like a sticking plaster that slowly releases medicine. We want to understand how this medication gets into your body when delivered this way. This is very important for making sure future medicines are used safely and effectively.

We're particularly interested in how different everyday situations might change how the medicine is absorbed. For example, does being warm, covering the patch, or doing some mild exercise affect how much of the medicine gets into your bloodstream? By understanding these things, doctors and pharmacists can give better advice on how to use these patches in the future.

It's important to know that this study is not designed to treat any health problems. We are looking for healthy volunteers because we want to see how the patch works in a normal body without other illnesses affecting the results. This type of research helps us build a full picture of how medicines work before they are used more widely.

Key takeaways

Tests how a medicine patch works in the body.
Looks at effects of heat, covering, and exercise.
Recruiting healthy adults aged 18 and over.
Not for treating any illness; helps medical research.
Involves clinic visits and blood tests.
You can stop participating at any time.

Who may be eligible?

To be part of this study, you need to be a healthy adult. This means you generally feel well and don't have any long-term health conditions that might interfere with how your body handles medicines.

We are looking for both men and women to participate. If you are aged 18 or older, you could be eligible. There isn't an upper age limit mentioned, but good general health is key.

The research team will review your health information to make sure this study is right for you and safe for you to take part in.

Quick self-check

Are you 18 years old or older?
Do you consider yourself generally healthy?
Are you willing to attend regular clinic visits?
Are you comfortable with having blood samples taken?
Do you understand this study is not for treating illness?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you'll be one of the healthy volunteers helping us learn about this medicine patch. The study is called a 'four-way change-over study', which means you'll try the patch under four different conditions, and these conditions will be given in a mixed-up order to make the results fair.

You will receive the active study patch on several occasions. During each period, we will see how things like moderate heat, having the patch covered, or doing some light exercise affect the medicine. This will involve regular blood samples to measure how much of the medicine is in your body and checking for any side effects.

The study involves several visits to the clinic, and each visit or period might last for a full day or potentially involve an overnight stay, followed by outpatient appointments. The total time you'll be involved in the study will be explained in detail by the study team.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. You won't personally benefit from the medication in this study as it's not being used to treat any illness, but you'll be contributing valuable information that helps medical science. Risks might include mild skin irritation from the patch, discomfort from blood tests, or potential side effects from the medication itself, though these are typically monitored very closely in Phase I studies. You have the absolute right to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Germany

Common questions

What is esflurbiprofen?

Esflurbiprofen is a type of anti-inflammatory medicine, similar to over-the-counter painkillers, but in this study, it's being given through a skin patch.

Will this study treat a medical condition I have?

No, this study is about understanding how a medicine patch works in healthy people, not about treating any existing health problems.

What does 'healthy volunteers' mean?

It means people who are generally well and don't have major ongoing health issues that might affect how the medicine works or might make taking part unsafe.

Will I have to stay overnight at a clinic?

It's possible some parts of the study will require overnight stays at a research clinic. The study team will give you all the details.

Can I stop participating if I change my mind?

Yes, you are free to withdraw from the study at any point without needing a reason, and it won't affect your future medical care.