Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

AN OPEN LABEL, TWO PERIODS, TWO SEQUENCES, CROSSOVER, RANDOMIZED MULTIPLE DOSE BIOEQUIVALENCE STUDY OF GUANFACINE 7 MG PROLONGED-RELEASE TABLETS (TEST FORMULATION) VS. EQUAL DOSE OF INTUNIV® PROLONGED-RELEASE TABLETS (REFERENCE FORMULATION) IN HEALTHY MALE VOLUNTEERS UNDER FASTING CONDITIONS

This research is looking at two versions of a medicine called guanfacine prolonged-release tablets. One is a new version (the 'test' medicine) and the other is an existing one called Intuniv® (the 'reference' medicine). The main goal is to see if these two medicines are absorbed and act in your body in the same way. This is called a 'bioequivalence' study. We are looking for healthy male volunteers to help us compare these medicines. Participants will take both medicines at different times, so we can directly compare their effects and ensure the new version works just like the established one. This type of study is an early step in checking new medicines.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

neuraxpharm Arzneimittel GmbH

Enrolment target

Start

19 Jan 2024

Study performed on healthy volunteers.

What is this study about?

Imagine you have a well-known brand of a certain type of tablet, and another company makes a very similar tablet. This study is all about checking if that new, similar tablet acts in your body in exactly the same way as the original, established one. The medicine we're looking at is called guanfacine, specifically a version that releases slowly over time (prolonged-release).

The main purpose is to make sure that the amount of medicine that gets into your bloodstream and how quickly it gets there is the same for both the new tablet and the existing Intuniv® tablet. If they are the same, it means they are 'bioequivalent' – essentially, they work identically in your body. This is a really important step when developing new medicines, as it helps confirm they will be just as effective and safe as the medicines we already trust.

To do this, healthy male volunteers will be asked to take both tablets at different times. By carefully measuring the levels of the medicine in their blood after they take each tablet, we can compare them directly. This helps doctors and patients know that when they switch between different versions of a medication, they can expect the same results.

Key takeaways

This study compares a new guanfacine tablet with an existing one.
It aims to see if both tablets work truly similarly in your body.
Only healthy adult men are eligible to take part.
Your participation helps ensure new medicines are safe and effective.
You'll have health checks and give blood samples during the study.

Who may be eligible?

This study is looking for healthy men to take part. Being 'healthy' means you don't have any major ongoing health problems and generally feel well. The study is particularly interested in your general fitness and how your body handles medicines.

You need to be an adult, aged 18 years or older. There is no upper age limit, meaning as long as you are healthy according to other study checks, your age won't stop you from joining.

Because of the way this particular study is designed (comparing how medicines are processed in the body), it is only open to men. Women are not eligible for this specific trial.

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 with no major ongoing medical conditions?
Are you able to follow study instructions, including fasting for certain periods?
Are you able to commit to staying at the study clinic for short periods and attend follow-up visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll go through a screening process to make sure you're healthy enough for the study. This usually involves a health check, some blood tests, and a medical history review. If you're eligible, you'll be randomly assigned to one of two groups, which determines the order in which you take the medicines.

You'll complete two main periods of study. In each period, you'll stay at the study clinic for a short time, typically a day or two, during which you'll receive one of the study medicines. After taking the medicine, blood samples will be taken regularly over several hours to see how the medicine levels change in your body. You'll also have regular health checks. There will be a 'washout' period between these two stays, which is a break where you don't take any study medicine, to make sure the first medicine has completely left your system before you take the second one.

After both study periods, there will be a final check-up to ensure you are well. The total duration of your involvement, including screening, both dosing periods, and follow-up, will be clearly explained to you.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit is contributing to medical research and helping to ensure new medicines are safe and effective. You might also receive a health check-up as part of the screening process. Potential risks are generally mild and temporary, such as discomfort from blood draws or possible side effects from the study medication, which will be fully explained before you agree to participate. You have the right to 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.

—
Unverified
Romania

Common questions

What does 'prolonged-release' mean?

It means the medicine is designed to release slowly into your body over several hours, so you don't have to take it as often.

Why are you only studying men?

Some studies focus on one sex to simplify the initial comparison of medicines, as differences between men and women can sometimes affect how drugs are handled by the body.

What is 'bioequivalence'?

It means two medicines are absorbed and act in your body in a very similar way, so they can be expected to have the same effects.

Will I know which medicine I'm taking?

This is an 'open-label' study, which means both you and the study team will know which medicine you are taking at each stage.

Will I get paid for taking part?

Often, studies involving healthy volunteers offer payment for your time, travel, and inconvenience. This will be fully discussed with you by the study team.