AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A study comparing different dosage forms of midazolam and how they are taken up in the body.

This study aims to understand how a medicine called midazolam is absorbed by the body when given in different forms. Midazolam can be used for things like helping people relax before an operation or for treating seizures. Researchers want to compare how quickly and how much of the medicine gets into the bloodstream depending on how it's given. This is a very early-stage study involving healthy men aged 18 and older, and it’s done under fasting conditions, meaning participants won't have eaten for a while. The information gathered will help doctors decide the best way to give midazolam for different medical situations.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

MIDAS Pharma GmbH

Enrolment target

Start

26 May 2026

Bioavailability Study under Fasting Conditions

What is this study about?

This study is about a medicine called midazolam. It's a drug often used in hospitals to help people relax or to treat seizures. Sometimes, medicines can be given in different ways, for example, as a tablet, an injection, or even a liquid that dissolves in the mouth. This study wants to find out if the way midazolam is given changes how well or how quickly it gets into your body and starts to work. Think of it like comparing how quickly your body uses up a vitamin if you chew it versus swallowing a pill whole.

The researchers will compare different forms of midazolam to see which one gets into the bloodstream most effectively. This kind of study is called a 'bioavailability' study, which simply means looking at how much of a drug actually reaches its target in the body. It’s done under specific conditions, like when a person hasn't eaten for a certain period, because food can sometimes affect how medicines are absorbed.

Understanding how midazolam is absorbed in different forms is really important. It helps doctors decide the best way to give the medicine for different health problems, making sure people get the right amount of medication at the right time. This research helps to make treatments safer and more effective for future patients.

Key takeaways

This study compares how different forms of midazolam medicine enter the body.
It's an early-stage study involving healthy adult men.
Participation involves taking midazolam and having blood samples taken.
It helps improve how doctors give this medicine in the future.
You can stop participating at any time if you change your mind.

Who may be eligible?

This study is looking for volunteers who are healthy men. You need to be at least 18 years old to take part, and there's no upper age limit, as long as you meet the other health requirements.

Because this is an early-stage study, it's usually for people who are generally well and don't have any major ongoing health problems. This helps the researchers focus on how the medicine works without other health conditions getting in the way.

Specific details about other health conditions or medications you might be taking would be discussed with the study team to make sure it's safe for you to participate.

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 male?
Are you 18 years old or older?
Are you generally healthy, without major ongoing medical conditions?
Are you able to follow study instructions, including fasting?
Are you able to attend several clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a health check-up to make sure you're suitable. The study will involve several visits to a clinic. During these visits, you’ll be given different forms of midazolam, and then clinic staff will take blood samples regularly over a period of time. This is how they measure how much of the medicine is in your body and how quickly it gets there. You will likely be asked to fast, meaning not eat any food, for a certain amount of time before receiving the medicine. The total length of your involvement in the study, including all visits and follow-ups, would be explained fully by the research team.

Potential risks and benefits

Potential benefits of taking part include contributing to medical science, which can lead to better treatments for countless others in the future. You will also receive careful medical monitoring throughout the study. Every medicine has potential side effects, and midazolam can cause drowsiness or lightheadedness, which would be carefully managed by the study team. You would be fully informed of all known risks before deciding to participate, and importantly, you are free 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
Czechia

Common questions

What is midazolam used for?

Midazolam is a medicine often used to help people relax before medical procedures or to treat conditions like seizures.

What does 'fasting conditions' mean?

It means you won't be allowed to eat or drink anything (except water) for a certain amount of time before you're given the medicine in the study.

Will I have to stay overnight?

The study team will explain the full schedule, including whether any overnight stays are required to monitor the medicine's effects.

Can I get paid for taking part?

Sometimes studies offer payment for your time and inconvenience; this information will be provided by the study team.

What happens to my information?

Your personal information will be kept private and confidential, and any results will only refer to you by a code, not your name.