Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence study of GP-IMP-001 with regards to reference product

This study is called a 'bioequivalence' study. It means we want to see if a new version of a medicine, named GP-IMP-001, is absorbed by your body in the same way as an older, already approved version. This is important to ensure that the new drug will work just as well and be just as safe. We are looking for healthy male volunteers, aged 18 or older, to take part. This is an early phase of drug development, focusing on understanding how the drug behaves in the human body. Your participation would help us confirm if GP-IMP-001 is a good alternative to the current treatment.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Gebro Pharma GmbH

Enrolment target

Start

19 Dec 2024

healthy volunteers

What is this study about?

This research is looking at a new medicine called GP-IMP-001. When a drug is developed, it goes through many tests to make sure it's safe and effective. Sometimes, a new version of an existing drug is made, and we need to check that it works just as well.

That's where this study comes in. It's called a 'bioequivalence' study. This simply means we are comparing how your body handles the new medicine (GP-IMP-001) compared to a medicine that is already approved and used. We want to see if the main ingredient in both drugs gets into your bloodstream at the same speed and in the same amount. If they do, it means they are 'bioequivalent' and should have the same effects.

Understanding how GP-IMP-001 behaves in the body is a very important step. If this study shows that the new drug is similar enough to the existing one, it could potentially become available as another option for treatment in the future. Your help in this early stage can make a big difference in bringing new medicines safely to patients.

Key takeaways

This study compares a new drug (GP-IMP-001) with an existing one.
It needs healthy male volunteers, 18 or older.
The goal is to see if the new drug is absorbed similarly by the body.
Participation involves taking the drug and having blood tests.
Your involvement helps bring potentially new medicines to patients.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, we are specifically looking for healthy male volunteers. This means you should generally be in good health and not have any serious ongoing medical conditions.

You must be at least 18 years old to take part. There is no upper age limit specified, as long as you are healthy enough to participate.

Because this is an early-stage study, it's very important that participants fit specific criteria to keep everyone safe and ensure reliable results. If you are a man aged 18 or older and consider yourself healthy, you might be a good fit.

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?
Do you consider yourself generally healthy?
Do you not have any major ongoing health problems?
Are you comfortable with taking a new medication and having blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given the study medication, GP-IMP-001, at our study centre. We will then take several blood samples over a set period to measure how the drug is absorbed into your body. This will usually involve multiple visits to the clinic.

Throughout the study, nurses and doctors will monitor your health closely. You'll have regular check-ups, and we'll ask you about any symptoms or feelings you experience. The exact number of visits, tests, and the total length of your participation will be fully explained to you before you agree to join. You will be given a detailed schedule outlining everything involved.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. You might not directly benefit from taking GP-IMP-001 itself, as it's an investigational drug, but your participation is invaluable for advancing medical knowledge. Potential risks could include side effects from the medication, discomfort from blood draws, or the time commitment. All known risks will be thoroughly explained to you, and your safety is our top priority. Remember, you can withdraw from the study at any time, for any reason, without it affecting your future 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 does 'bioequivalence' mean?

It means we're checking if the new drug (GP-IMP-001) is absorbed by your body in the same way as an already approved drug.

Who can take part in this study?

We are looking for healthy male volunteers who are 18 years old or older.

Will I become healthier by taking part?

The main purpose of this study is not to improve your health, but to gather information about a new drug. You might not get a direct health benefit.

What kind of tests will I have?

The main tests will be blood samples taken at different times after you receive the study medication.

Can I stop participating if I change my mind?

Yes, you can leave the study at any time without having to give a reason, and it won't affect your medical care.