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 fasting conditions.
This research study is looking at two types of a medicine called Pyridostigmine Bromide. One is a new version from Greece, and the other is a commonly used one called Mestinon from Germany. Both are 180mg prolonged-release tablets. The main aim is to check if these two medicines are absorbed and work in the body in the same way when given to healthy men and women. This is called a 'bioequivalence study' and it's important for ensuring that different versions of a medicine are equally effective. Participants will try both medicines at different times to allow for a fair comparison, all while being carefully monitored.
At a glance
What is this study about?
Imagine you have a headache, and you can buy paracetamol from different brands. This study is a bit like that, but for a medicine used to treat a condition called myasthenia gravis. Myasthenia gravis is a long-term condition that causes muscle weakness. The medicine, called Pyridostigmine Bromide, helps improve muscle strength.
Researchers are comparing a new version of this medicine from a company in Greece with a well-known version called Mestinon from a company in Germany. Both are meant to release the medicine slowly over time. The main goal is to see if the new medicine works in the body in the same way as the established one. This means checking if it gets absorbed at the same rate and reaches similar levels in the blood.
This kind of study, called a bioequivalence study, is a standard and important step when a new version of an existing medicine is developed. It helps regulatory bodies, like the NHS, confirm that the new medicine will be just as safe and effective as the one already in use, even though it might come from a different manufacturer. This ensures patients get consistent treatment, no matter which approved version of the medicine they receive.
Key takeaways
- This study compares two versions of a medicine for myasthenia gravis.
- It's for healthy adult men and women.
- The goal is to see if the medicines work similarly in the body.
- You would receive both medicines during the study, at different times.
- Your participation helps ensure new medicines are safe and effective.
Who may be eligible?
This study is looking for healthy volunteers, meaning people who don't have any major ongoing health problems. Both men and women are welcome to take part.
You need to be an adult, aged 18 years or older. There is no upper age limit, as long as you are generally healthy.
Because this study involves comparing how a medicine is absorbed on an empty stomach, you might need to avoid certain foods or drinks before taking the study medication. The study team will explain all the specific requirements if you are interested.
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?
- Do you consider yourself generally healthy?
- Are you able to attend several clinic visits?
- Are you willing to have blood samples taken?
- Can you follow specific instructions like fasting before medication?
What does participation involve?
If you decide to take part, you'll be part of a 'cross-over' study. This means you will receive both medicines being tested, but at different times. For example, you might take Medicine A first, then after a break, you'll take Medicine B. This allows researchers to compare the medicines fairly in each person.
The study involves visits to a clinic. You'll have blood samples taken regularly after you take the medication to measure how much of the medicine is in your body. There will also be health checks, including a physical exam and blood tests, to make sure you're well enough to participate and to monitor your health throughout the study. You will be asked to fast before taking the medication on certain study days. The total duration of your participation, including all visits and follow-up, will be explained in detail by the study team.
Potential risks and benefits
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Common questions
What is 'bioequivalence'?
It means checking if two versions of a medicine work the same way in the body, so they can be considered interchangeable.
Do I have to have myasthenia gravis to join?
No, this study is for healthy volunteers, not people with myasthenia gravis.
Will I receive both medicines?
Yes, you will try both the new medicine and the established one at different times during the study.
Will I be paid for taking part?
Payment for participation in research studies varies and will be discussed during your first visit if you are eligible.
How long will I need to be in the study?
The total time commitment, including visits and follow-up, will be fully 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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