Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence of Metamizole Sodium 500 mg Film-Coated Tablets in Healthy Participants Under Fasting Conditions.

This research is looking at a common pain medication called Metamizole. The main goal is to see if a new tablet form (a 500mg film-coated tablet) acts in the body in the same way as an already approved version. This is called a 'bioequivalence' study. It helps ensure that any new medicine or new way of making a medicine is just as safe and effective as what's already out there. Healthy people are needed for this study, and they will take the medicine after not eating for a while. It's an important step in making sure medicines are reliable for everyone.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Alkaloid AD Skopje

Enrolment target

Start

26 Nov 2024

No medical condition.

What is this study about?

This study is about a well-known pain medication called Metamizole. When a company wants to introduce a new version of an existing medicine, perhaps a slightly different tablet or one made by another manufacturer, they need to prove it works just as well. This is crucial for your safety and to make sure you get the proper treatment.

That's where 'bioequivalence' comes in. It's a fancy word for checking if two different versions of the same medicine deliver the same amount of the drug to your body at the same speed. If they do, then they are considered 'bioequivalent', meaning they should have the same effect.

So, this study is testing if a new Metamizole 500mg tablet is identical in how it works inside your body compared to a standard Metamizole tablet. This type of research is a standard and very important part of bringing medicines to people, ensuring quality and effectiveness.

Key takeaways

This study compares a new version of the painkiller Metamizole to an existing one.
It's for healthy adults (age 18 and over, both men and women).
The goal is to ensure the new tablet works in the body just like the standard one.
You'll need to fast before taking the medicine and have blood samples taken.
Participation helps bring safe and effective medicines to market.

Who may be eligible?

This study is looking for healthy adults. You need to be at least 18 years old to take part, and there's no upper age limit mentioned.

Both men and women are welcome to participate. The study aims to gather information from a general adult population.

Because this study is testing how the medicine behaves in healthy bodies, you should not have any serious or ongoing medical conditions. They will check your health carefully to make sure it's safe for you 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 healthy with no serious medical conditions?
Are you comfortable having blood samples taken?
Are you able to follow specific instructions, like fasting before visits?
Are you available for the required clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to visit the study clinic usually a few times. You'll need to avoid eating for a certain period before taking the study medication – this is called 'fasting conditions' and helps them get clear results. You'll take the Metamizole tablet, and then nurses or doctors will take small blood samples from you over several hours. This is to measure how the medicine gets into and leaves your body. You'll be carefully monitored during these visits, and there will be follow-up checks to make sure you are well. The total duration of your involvement could range from a few days to a couple of weeks, depending on the study design.

Potential risks and benefits

The main benefit of taking part is contributing to medical science and helping to ensure new medications are safe and work effectively for future patients. You might also receive some financial compensation for your time and travel. Possible risks include discomfort from blood samples, or mild side effects from Metamizole, such as stomach upset or dizziness, similar to what you might experience with any common painkiller. Your health will be closely monitored, and you are free to withdraw from the study at any time, for any reason, without it affecting your 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
Portugal

Common questions

What is Metamizole?

Metamizole is a medication used to relieve pain and reduce fever.

Why do they need healthy people for this study?

They need healthy people to understand how the medicine works in a typical body, without other health problems affecting the results.

What does 'fasting conditions' mean?

It means you won't be allowed to eat for a certain time before taking the medicine, usually overnight, to ensure consistent results.

Will I receive payment for taking part?

Many clinical trials offer payment for your time and inconvenience, but you'd need to confirm this with the study team.

Is this a new, untested medicine?

No, Metamizole is an established medicine. This study is checking a new version or way of making the tablet to ensure it works the same as existing ones.