AuthorisedHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence of two transdermal therapeutic systems delivering 100 mcg/h fentanyl

This research is looking at two types of patches that deliver a pain medicine called fentanyl. One is an existing patch, and the other is a new version. The main goal is to see if the new patch releases the medicine into the body at the same speed and in the same amount as the established patch. This is important to make sure that patients who use these patches for pain relief get a consistent and effective dose, no matter which patch they use. Healthy adult volunteers are taking part to help us understand how the medicine is absorbed from each patch. This type of study is a common and necessary step before a new medicine or patch can be made widely available.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

CCDRD Cooperative Clinical Drug Research and Development AG, Lavipharm S.A.

Enrolment target

Start

03 Apr 2025

Bioequivalence trial in healthy volunteers

What is this study about?

This study is a type of research called a 'bioequivalence trial'. In simple terms, it's comparing two different patches that contain the same pain medicine, fentanyl, which is a strong painkiller. Both patches are designed to deliver 100 micrograms of fentanyl into your body every hour through your skin. The purpose is to check if these two patches deliver the medicine in exactly the same way and at the same rate.

Imagine you have two different brands of a common tablet, like paracetamol. Even though they both contain the same amount of paracetamol, scientists need to make sure your body absorbs the active ingredient from both brands in the same way. This study is doing something similar, but with pain patches.

Why is this important? Because if a new patch is developed, we need to be absolutely sure it works just as well and is as safe as the already approved patch. This means patients can switch between patches, or have other options, knowing they will get the same consistent pain relief.

Key takeaways

This study compares two fentanyl patches to ensure they work the same.
It uses healthy adults to understand how the medicine is absorbed.
Both men and women aged 18 and over can take part.
Participation involves wearing patches and giving blood samples.
The goal is to ensure consistent and safe pain relief options for patients.
Your health will be closely monitored throughout the study.

Who may be eligible?

This study is looking for healthy adults. You need to be at least 18 years old to take part, and there's no upper age limit mentioned, meaning older adults can also be considered.

Both men and women are welcome to participate in this research. The study needs healthy people because it helps researchers understand how the patches work without other health conditions affecting the results.

Being 'healthy' usually means you don't have any major ongoing medical conditions, aren't taking certain medications, and meet other specific health checks performed 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 healthy with no major ongoing medical conditions?
Are you able to attend several appointments at a clinic?
Are you comfortable with blood tests?
Do you understand that you will be exposed to a pain medication?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you would likely have a few visits to the study clinic. During these visits, the study team would give you one of the fentanyl patches to wear. They would then take regular blood samples to measure how much fentanyl is in your system over a set period. This helps them compare how the two different patches deliver the medicine.

They might also perform other tests to check your general health throughout the study. You would probably switch between wearing the different patches at different times, with a break in between, so they can compare results fairly. The total duration of your involvement, including all visits and follow-ups, would be explained in detail before you agree to take part.

Potential risks and benefits

The main benefit of taking part in this study is helping to advance medical knowledge, which can ultimately lead to more choices for effective pain relief. You might also receive free health checks during the study. Potential risks include discomfort from blood draws, and possible side effects from the fentanyl patches, even in healthy individuals, such as feeling sleepy, sick, or dizzy. You will be closely monitored for any adverse effects. Remember, you can choose to leave 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.

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Unverified
Bulgaria

Common questions

What is fentanyl?

Fentanyl is a powerful pain-relieving medicine, usually used for severe or ongoing pain. It belongs to a group of medicines called opioids.

Why do you need healthy volunteers for a pain medicine study?

Healthy volunteers help researchers understand how the patches work in a general way, without other health problems affecting the results. This is a standard first step for this type of research.

What does '100 mcg/h' mean?

It means the patch is designed to deliver 100 micrograms (mcg) of fentanyl into your body every hour (h). Micrograms are a very small unit of measurement.

Will I feel pain relief if I'm not in pain?

You might feel some effects of the medicine, like drowsiness or dizziness, even if you are not in pain, as fentanyl is a powerful drug.

Will I be paid for taking part?

Often, studies involving healthy volunteers offer some payment to compensate for your time and travel. This will be explained in detail if you are interested.