AuthorisedHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence study of two sulodexide preparations: Sulodexide Intexo 250 LRU and Vessel Due F 250 LRU cps

This research is looking at two types of a medicine called sulodexide. It's a bioequivalence study, which means scientists want to check if both versions deliver the same amount of the active medicine into your body at the same speed. This is important because it tells us if different brands of the same medicine will work in the same way. Healthy adult volunteers are needed for this study, and it helps ensure that new or generic versions of medications are just as safe and effective as existing ones. There's no specific medical condition being treated; it's purely about comparing how the two medicines behave once taken.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Intexo Societa Benefit S.r.l.

Enrolment target

Start

19 Sep 2024

No medical condition.

What is this study about?

Imagine you have a headache and take a painkiller. You expect it to work in a certain way. Now, what if a different company made the *exact same* painkiller? You'd want to be sure it would work just as well, right? That's exactly what this study is about, but for a medicine called sulodexide.

Researchers want to compare two versions of sulodexide: one called Sulodexide Intexo and another called Vessel Due F. They're both designed to deliver the same medicine. The main goal is to see if, once you take them, both versions release the active ingredient into your bloodstream at the same rate and in the same amount. This is super important because it helps doctors and patients feel confident that if they switch between different brands of the same medicine, they'll get the same effect.

This type of study is called a 'bioequivalence' study. It's a standard and necessary part of developing new medications or bringing generic versions to market in the UK and worldwide. It's not about finding a new treatment for an illness; instead, it's about making sure that similar medicines are truly similar in how they work inside you.

Key takeaways

Compares two versions of sulodexide medicine.
Aims to ensure they work the same way in your body.
For healthy adults aged 18 and over.
Not a treatment for any illness.
Involves clinic visits and blood tests.
Helps make medicines safer and more effective for everyone.

Who may be eligible?

For this study, researchers are looking for healthy adults. You need to be at least 18 years old, and there's no upper age limit, meaning older adults are welcome too. They're happy for both men and women to take part.

Because this study is about how a medicine acts in a healthy body, you shouldn't have any serious or ongoing medical conditions. The researchers will check your general health to make sure it's safe for you to participate.

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?
Do you not have any major ongoing medical conditions?
Are you able to visit a clinic for study appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given doses of both sulodexide preparations. This usually involves a few visits to a clinic over a short period. During these visits, medical staff would take blood samples to measure how much of the medicine is in your body over time. They might also check your blood pressure and heart rate. You’d be carefully monitored throughout. The total duration of your involvement could range from a few days to a couple of weeks, depending on the specific study design.

Potential risks and benefits

Participating in research always carries some potential risks, like discomfort from blood draws or possible side effects from the medication, even though it's given to healthy people. However, participants are closely monitored by medical professionals. The potential benefits aren't directly to your health, as this isn't a treatment study, but you'd be contributing vital information that helps ensure safer and more effective medicines for everyone in the future. You always have the right 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 exactly is sulodexide used for?

While this study isn't treating a condition, sulodexide is a medicine often used to help with circulation and blood vessel health in various medical conditions.

Will I be given a placebo (dummy pill)?

Bioequivalence studies like this typically compare an active medicine to another active medicine, not usually to a placebo.

How many times will I need to visit the clinic?

The exact number of visits will be explained by the study team, but these types of studies often involve several visits, usually over a short period.

Do I get paid for taking part?

Some studies offer payment or cover travel expenses for your time and inconvenience, but this varies. You should ask the study team about this.

Is this a new medicine?

No, this study is comparing two versions of an existing medicine to ensure they work in the same way.