Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Clinical trial to compare availability in the body of the active substance nicotine as well as patch adhesion of the newly developed patch LTS Nicotine TTS vs. Nicotinell® (21 mg/24 h) in healthy smokers after single patch application

This study is looking at a new nicotine patch called LTS Nicotine TTS. Researchers want to find out two main things: first, how much nicotine from this new patch gets into the body compared to a well-known patch called Nicotinell (21 mg/24 h). Second, they want to see how well the new patch stays on the skin. This study involves healthy adult smokers who will wear a single patch. It's an early-stage study that focuses on understanding how the patch works in the body and how well it sticks, rather than studying if it helps people quit smoking. It's a key step to make sure new medicines work as expected.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

LTS LOHMANN Therapie-Systeme AG

Enrolment target

Start

22 May 2023

bioequivalence and patch adhesion trial therapeutical indication not studied

What is this study about?

This study is about a new nicotine patch and how it works in the body. Imagine you're taking a vitamin; this study wants to see if the new nicotine patch delivers nicotine into your system in a similar way to an existing, approved nicotine patch. It's a bit like comparing two different ways to deliver a message – does the new way get the same message across, and just as effectively?

The other main thing this study will look at is how well the new patch sticks to your skin. If a patch doesn't stick properly, it might not deliver the medicine as it should, so this is an important check. This kind of study is a necessary early step when developing new medicines to make sure they are reliable and deliver the right amount of medicine.

It's important to know that this study isn't about whether the patch helps people stop smoking; it's purely focused on how the nicotine is absorbed and how well the patch stays on. It's a foundational study to ensure the patch itself works as intended before it can be looked at for its main purpose.

Key takeaways

This study compares a new nicotine patch to an existing one.
It checks how much nicotine gets into the body and how well the patch sticks.
It's for healthy adult smokers aged 18 and over.
This is an early-stage study, not focused on helping people quit smoking.
Participation involves wearing a patch and blood tests.

Who may be eligible?

This study is looking for healthy adult smokers to take part.

You might be able to join if you are 18 years old or older. There is no upper age limit for this study, so older adults can also participate.

Both men and women are welcome to take part in this study.

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 a smoker?
Are you generally in good health?
Are you able to attend clinic visits (if required)?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will wear a single patch. Researchers will then check how much nicotine gets into your bloodstream over time. They will also look at how well the patch stays on your skin. The study does not mention specific visits, but typically, these types of studies involve several visits to a clinic for blood tests and checks on the patch. The total duration of the study is not specified but is usually short, focusing on a single application of the patch.

Potential risks and benefits

Taking part in any study always has some considerations. A potential benefit could be contributing to medical science, which helps bring new treatments to others. There are usually no direct health benefits for participants in this type of early-stage study. Potential risks are generally low, such as mild skin irritation from the patch or discomfort from blood tests. You will have full 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.

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Unverified
Germany

Common questions

What is the main goal of this study?

The main goal is to see how much nicotine from a new patch gets into the body and how well the patch sticks, compared to a well-known existing patch.

Will this study help me quit smoking?

No, this study is not designed to help people stop smoking. It focuses on how the patch works in the body, not its effects on quitting.

Who can take part in this study?

Healthy adult smokers, aged 18 or older, both men and women, can take part.

What will I have to do if I join?

You will wear a single study patch, and researchers will take blood samples and check how well the patch stays on your skin.

Are there any risks to joining?

Risks are generally low, such as possible skin irritation from the patch or discomfort from blood tests.