AuthorisedHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Etude de bioéquivalence entre Circadin et Melatonin PILEJE LP 2 mg

This study, called a bioequivalence study, is looking at two different sustained-release melatonin medicines: Circadin and Melatonin PILEJE LP 2 mg. Melatonin is a natural hormone that helps control sleep. The main goal is to see if, when taken by men aged 18 and older who experience difficulty sleeping (insomnia), these two medicines are absorbed and behave the same way in the body. This kind of study helps ensure that different versions of a medicine are just as effective. Participants will be taking the medicines as part of this research. It's a key first step in understanding how these medications work.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Pileje

Enrolment target

Start

28 Aug 2025

Primary insomnia characterized by poor quality of sleep

What is this study about?

This study is comparing two slow-release melatonin medicines, Circadin and Melatonin PILEJE LP 2 mg. Melatonin is a natural hormone produced by your body that helps you know when to go to sleep and when to wake up. For some people, problems with sleep, known as insomnia, can be linked to issues with their natural melatonin levels.

Researchers want to see if these two different melatonin medicines are similar in how they work inside the body. This is called a 'bioequivalence' study. It means they're checking if the medicines are absorbed at the same rate and reach the same levels in the blood, which is important for them to have similar effects on sleep.

Understanding how different versions of melatonin medicines work is an important step in making sure people with sleep problems have effective treatment options. This study helps ensure that if a new version of a medication is developed, it works just as well as an existing one.

Key takeaways

This study compares two different melatonin medicines for sleep problems.
It's for men aged 18 and over who have difficulty sleeping.
The aim is to see if the medicines work similarly in the body.
Participation involves taking medicines and providing blood samples.
It helps ensure new medicines are just as effective.
You can withdraw from the study at any time.

Who may be eligible?

This study is specifically looking for men who are 18 years old or older. You should be experiencing what's called 'primary insomnia', which means you have trouble sleeping, and it's not due to another health condition or medication.

To be eligible, your insomnia needs to be characterised by poor quality of sleep. This means you might find it hard to fall asleep, stay asleep, or you might wake up feeling tired. The researchers will check this as part of the screening process.

If you are a woman, or under 18, you won't be able to take part in this particular study. The research team will need to make sure you meet all the other health criteria too.

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.

I am a man.
I am 18 years old or older.
I have ongoing problems with my sleep.
My sleep problems are not due to another known health condition or medication.

Answer every question to see your result.

What does participation involve?

Details about taking part aren't fully described here, but generally in this type of study, you would visit a clinic several times. You'd likely be given one of the melatonin medicines, and then blood samples would be taken regularly over a set period to see how the medicine is absorbed and cleared from your body. You might also be asked to complete questionnaires about your sleep.

This process would then be repeated with the other melatonin medicine, usually after a 'washout' period where you don't take any study medication. The total time you'd be involved in the study, including all visits and follow-up, would be made clear to you before you agree to participate.

Potential risks and benefits

Potential benefits of taking part could include contributing to scientific understanding of melatonin medicines and having your health monitored by a medical team. As with any medication, there can be potential risks, such as side effects from the melatonin or discomfort from blood tests. These would be explained in detail before you agree to take part. Remember, you can always ask questions, and you have the right to withdraw from the study at any time without giving a reason, and it won't 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
France

Common questions

What is primary insomnia?

Primary insomnia is when you have trouble sleeping (like difficulty falling or staying asleep) and it's not caused by another medical problem, medication, or substance.

What is melatonin?

Melatonin is a natural hormone made by your body that helps control your sleep-wake cycles. It tells your body when it's time to sleep.

What does 'bioequivalence' mean?

Bioequivalence means that two different versions of a medicine are absorbed into your body in a similar way and at a similar rate, so they should work in the same way.

Will I know which medicine I'm getting?

In this type of study, you might or might not know which medicine you're taking at a given time. The researchers will explain this to you – it's often done to keep the study fair and unbiased.

Who is funding this study?

The information provided doesn't state who is funding the study. This is a good question to ask the research team if you are interested in participating.