An open label, randomized, single-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 fed conditions.
This study is looking at two different versions of a medicine called pyridostigmine bromide, which is used to treat a condition called myasthenia gravis. One version is a new generic tablet from Greece, and the other is an existing slow-release tablet from Germany. The main goal is to check if these two versions deliver the medicine into the body in the same way. This is called a 'bioequivalence' study. Healthy adult men and women will take these medicines after eating, and researchers will measure how the drug levels change in their bodies. This type of study is important to ensure that new medicines work just as well as established ones.
At a glance
What is this study about?
This research study is about a medicine called pyridostigmine bromide. This medicine is often used to help people who have a condition called myasthenia gravis, which causes muscle weakness. For those with myasthenia gravis, this medicine can help improve muscle strength and function.
The study has a specific goal: to compare two different versions of this medicine. One is a new tablet made in Greece, and the other is an existing, well-known slow-release tablet. The researchers want to find out if both medicines release into the body at the same speed and reach similar levels in the blood. This is important because it ensures that a newer, possibly more affordable, version of the medicine works just as effectively and safely as the original.
This kind of study is called a 'bioequivalence' study. It helps regulatory bodies, like the UK's Medicines and Healthcare products Regulatory Agency (MHRA), approve new generic medicines. When a new generic medicine is approved, it means it's considered to be just as good as the original, branded medicine. This study is an important step to ensure that patients with myasthenia gravis will have access to effective treatment options.
Key takeaways
- This study compares two versions of a drug for myasthenia gravis.
- It's a 'bioequivalence' study to see if a new generic drug works like an existing one.
- Healthy adult men and women are needed as volunteers.
- Participants will take both medicines at different times after eating.
- The goal is to ensure new medicines are safe and effective.
- Participation involves clinic visits and blood tests.
Who may be eligible?
To join this study, participants need to be healthy adults. This means you should not have any significant ongoing health problems or illnesses that would make taking part unsafe or affect the study results.
The study is open to both men and women. You must be at least 18 years old to be considered for participation. There isn't an upper age limit mentioned, but generally, participants would need to be fit enough to complete all study procedures safely.
Because this is a specific type of study measuring how medicine is absorbed, you would likely undergo medical checks to ensure you are healthy and that anything you take won't interfere with the study medicine. You would also need to be willing to follow all study instructions carefully.
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 healthy with no major ongoing medical conditions?
- Are you comfortable with regular blood tests?
- Are you able to follow specific instructions for taking medication and meals?
- Are you able to commit to several clinic visits?
What does participation involve?
If you decide to take part in this study, you would visit the study clinic multiple times. You'd be asked to take one of the two study medicines after eating a standard meal. On different occasions, you'd switch and take the other medicine (this is called a 'cross-over' design).
During your visits, blood samples would be taken regularly after you've taken the medicine. These samples help researchers measure how the medicine is absorbed and cleared from your body. You might also have other checks like blood pressure and heart rate monitoring. The total duration of your involvement, including all visits and follow-up, would be fully explained to you before you agree to participate.
Potential risks and benefits
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Common questions
What is myasthenia gravis?
Myasthenia gravis is a long-term condition that causes muscle weakness. It happens when the body's immune system mistakenly attacks healthy cells involved in muscle function.
What does 'bioequivalence' mean?
Bioequivalence means that two medicines, even if made by different companies, deliver the same amount of medicine to your body at the same speed. This ensures they work in the same way.
Why is this study only for healthy volunteers?
These early-stage studies often use healthy volunteers to clearly see how the medicine works in the body without other health conditions making the results harder to understand.
Will I know which medicine I'm taking?
It's an 'open label' study, which means both you and the study team will know which medicine you are taking at which time.
Will I get paid for taking part?
Compensation for your time and expenses is common in these types of studies, but the exact details would be explained by the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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