Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence of Betis®10 mg Film-Coated Tablets versus Clozan 10 mg tablets in Healthy Subjects

This research study is looking at a new medicine called Betis 10mg. We want to see if it works in the same way as a very similar existing medicine, Clozan 10mg, when taken by healthy adults. This type of study, called a bioequivalence study, is important because it helps scientists and doctors understand if two different versions of a medicine deliver the same amount of active ingredient to your body at the same speed. This means we can be confident that if a new version of a medicine is introduced, it will have the same effect as the original. This study involves healthy volunteers and is an early step in testing new medicines.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Synthon Chile LTDA.

Enrolment target

Start

14 May 2024

No medical condition.

What is this study about?

Imagine you have two different brands of the same common painkiller. Even though they both contain the same active ingredient, scientists need to make sure they work equally well in your body. This study, called a bioequivalence study, is doing just that for two medicines: a new one called Betis 10mg and an established one called Clozan 10mg.

The main goal is to see if your body absorbs and processes Betis 10mg in the exact same way as Clozan 10mg. This means checking if the amount of medicine that gets into your bloodstream, and how quickly it gets there, is effectively the same for both. This is a very common and important type of study when new versions of existing medicines are developed.

By comparing these two medicines in healthy volunteers, researchers can get a clear picture of how they behave in the human body. This crucial information helps ensure that if Betis 10mg is approved for use, doctors and patients can be confident it will have the same effects as Clozan 10mg.

Key takeaways

This study compares a new medicine (Betis 10mg) with an existing one (Clozan 10mg).
It's about making sure both medicines work the same way in the body.
Healthy adults aged 18 and over are needed.
Participation involves taking medicines and giving blood samples.
It helps ensure new medicines are as safe and effective as existing ones.

Who may be eligible?

This study is looking for healthy adults to take part. This means you should not have any ongoing medical conditions or illnesses that might affect how your body handles medicines. We are looking for people who are generally well and don't need regular medication for long-term health issues.

Anyone aged 18 years or older can be considered for this study. There is no upper age limit, as long as you are healthy enough to participate. Both men and women are welcome to apply to be part of this research.

To make sure you are suitable, the research team will do some checks, which might include a medical history review and possibly some basic health tests. These are to ensure your safety and the accuracy of the study results.

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 ongoing medical conditions?
Are you able to attend clinic visits?
Are you willing to provide blood samples?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be attending a clinic for a short period. You would receive both the Betis 10mg and Clozan 10mg medicines at different times, as directed by the study doctors. You wouldn't be taking both at the same time.

During your visits, the research team would typically take blood samples at specific times after you've taken the medicine. This helps them measure how much of the medicine is in your bloodstream. You might also have your blood pressure and heart rate checked regularly.

The total duration of your involvement, including all visits and follow-up, would be explained to you in detail before you agree to participate. You won't be expected to do anything without a full explanation first.

Potential risks and benefits

Taking part in any study has potential benefits. You might gain a better understanding of medical research and contribute to the development of new medicines that could help others. However, there are also potential risks, such as mild side effects from the medicines, discomfort from blood tests, or unforeseen reactions. The research team will explain all known risks and monitor you closely. Remember, you can choose to leave 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 does 'bioequivalence' mean?

It means we're checking if two versions of a medicine act the same way in your body, delivering the same amount of active ingredient at the same speed.

Do I need to be ill to join this study?

No, this study is specifically looking for healthy volunteers, meaning people who don't have any medical conditions.

What will I have to do if I take part?

You'll be given both medicines at different times and have blood samples taken to see how your body processes them.

Will I know which medicine I'm getting?

Typically, in these studies, participants might not know which medicine they are receiving at a particular time to keep the results unbiased. This will be explained to you fully.

How long will the study last for me?

The exact duration will be explained by the study team, but it will involve several visits to a clinic.