AuthorisedHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

An open label, randomized, multiple-dose, two-treatment, two-period, cross-over bioequivalence study comparing Pyridostigmine Bromide, P.R.Tab, 180 mg/tab, VIANEX S.A., Greece versus Mestinon® retard 180 mg/prolonged-release tablet, Viatris Healthcare GmbH, Germany, in healthy male and female volunteers under fasting conditions.

This research study is comparing two different versions of a medicine called pyridostigmine bromide. This medicine is used to treat a condition called myasthenia gravis, which causes muscle weakness. The study wants to find out if a new tablet, manufactured by VIANEX S.A. in Greece, works in the body in the same way as an existing tablet, Mestinon® retard, from Viatris Healthcare GmbH in Germany. Doctors call this 'bioequivalence'. Healthy adult men and women will take part, and they will receive both medications at different times to see how their bodies handle them, especially when they haven't eaten beforehand.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Vianex S.A.

Enrolment target

Start

02 Jun 2026

treatment of myasthenia gravis

What is this study about?

You might be wondering what this study is all about. Well, there's a medicine called pyridostigmine bromide that helps people with myasthenia gravis, a condition that causes muscles to become weak. This study is like a comparison test between two different versions of this medicine. One version is a new tablet made by a company called VIANEX in Greece, and the other is an existing tablet called Mestinon® retard from Viatris Healthcare in Germany.

The main goal is to check if these two tablets deliver the medicine to the body in exactly the same way. This is important because it means that if the new tablet works just like the older, established one, it can be considered an equivalent option for patients. This kind of study helps ensure that new medicines are safe and just as effective as the ones we already use.

Healthy men and women will be taking part. They will receive both medications at different times, and doctors will carefully measure how their bodies absorb and use the medicine. This helps them understand if the new tablet is just as good as the one already available for people who need it.

Key takeaways

This study compares two versions of medicine for myasthenia gravis.
It aims to see if a new tablet works exactly like an existing one.
Healthy adult men and women are needed.
Participants will receive both medications at different times.
The study helps ensure new medicines are effective and safe.

Who may be eligible?

To join this study, participants need to be healthy adults. You can be a man or a woman.

There isn't an upper age limit mentioned, but participants must be at least 18 years old.

Because this is a study for healthy volunteers, people with existing medical conditions, especially myasthenia gravis itself, would not be able to take part.

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 generally in good health?
Are you available to attend clinic visits?
Are you comfortable with blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be involved in what's called a 'cross-over' study. This means you would receive one of the study medications, and after a break, you would then receive the other medication. This allows researchers to compare how each medicine affects you.

During each part of the study, you would likely have a hospital stay or several clinic visits. Doctors would give you the study medication when you haven’t eaten (this is called 'fasting conditions'). They would then take regular blood samples to measure how much of the medicine is in your body over time. There would also be checks on your general health throughout the study. The total duration of your involvement, including the breaks between medications, would be explained to you in detail.

Potential risks and benefits

Patients who take part in studies like this often contribute to scientific knowledge that can help others in the future. However, there are potential risks, such as discomfort from blood draws, or possible side effects from the study medication, even though it's given to healthy people. You will receive a full explanation of all known or potential risks before you decide to participate. Remember, taking part in any study is entirely your choice, and you are free to withdraw at any time without giving a reason.

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 myasthenia gravis?

Myasthenia gravis is a long-term condition that causes muscles to become weak and tired easily because of a problem with the body's immune system.

What does 'bioequivalence' mean?

Bioequivalence means that two different versions of a medicine work in the body in the same way, delivering the same amount of medicine at the same speed.

Will I take both medications?

Yes, in this type of study, healthy volunteers receive both tablets at different times to allow for a direct comparison in the same person.

Why do healthy people take part in studies for medicines for people with illnesses?

Studies like this use healthy volunteers to understand how a medicine is absorbed and processed by the body without the complications of an existing illness, making the results clearer.

Will I be paid for taking part?

Payment for participation in clinical trials, particularly Phase I studies, is common to compensate for time and inconvenience. This would be explained in detail if you enquired further.