Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Single dose oral bioequivalence study of Cladribine 10 mg Tablets and Mavenclad® 10 mg tablets (Cladribine) in healthy adult human subjects under fed conditions

This study is looking at a new version of cladribine 10 mg tablets. Cladribine is a medication used for some conditions, but in this study, we are not treating any illness. We want to check if the new tablet acts in the body in the same way as an already approved cladribine tablet called Mavenclad®. This is called a 'bioequivalence study'. To do this, healthy adult men will be given a single dose of the medication after eating. The information gathered will help make sure that the new tablet is just as effective and safe as the existing one if it were to be used for patients in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

PharOS Pharmaceutical Oriented Servises Ltd., CCDRD Cooperative Clinical Drug Research and Development AG

Enrolment target

Start

08 Oct 2025

No therapeutic indication in the current trial with healthy volunteers.

What is this study about?

Imagine you have a headache and take a paracetamol tablet. Now, imagine a different company makes their own paracetamol tablet. This study is a bit like checking if that new paracetamol tablet works exactly the same way in your body as the one you usually take. We're doing this for a medication called cladribine.

Cladribine is an important medicine used to treat certain diseases, but this study isn't about treating those diseases. Instead, it's about comparing a new cladribine 10 mg tablet with an existing, approved cladribine 10 mg tablet (called Mavenclad®). We want to make sure the new tablet behaves exactly the same way in the body – that it's absorbed at the same speed and to the same amount. This is super important because it helps ensure that if the new tablet ever becomes available, it will be just as effective and safe as the original one for patients who need it.

This type of study is called a 'bioequivalence study' and is a standard part of testing new medications. It's done very early in the development process, usually with healthy volunteers, because we only want to see how the drug is handled by the body without other health conditions interfering. This helps scientific experts decide if the new tablet can be used in the future as an alternative to the existing one.

Key takeaways

This study compares two versions of cladribine tablets to see if they work the same way in the body.
It's a research study, not a treatment for any illness.
Only healthy adult men aged 18 or over can take part.
Participants will receive a single dose of medication after eating.
The study helps ensure new medications are as effective and safe as existing ones.

Who may be eligible?

This study is specifically looking for healthy adult men.

To take part, you must be 18 years old or older. There is no upper age limit.

Because this study is comparing how the medication works in the body, it's really important that participants are generally healthy and don't have any medical conditions that might affect how the drug is absorbed or processed.

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 male?
Are you 18 years old or older?
Are you generally healthy?
Do you not have any major ongoing medical conditions?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive a single dose of the study medication after eating. This will involve staying at a clinic for a short period so that doctors can collect blood samples at specific times. These samples help them measure how much of the medication is in your body and how quickly it's absorbed and removed. You'll have regular checks by doctors and nurses to make sure you are well. The total duration of your involvement, including any follow-up visits, would be explained in full by the study team.

Potential risks and benefits

The main benefit of taking part is contributing to medical science and helping to ensure new medications are as safe and effective as possible. While this study is generally considered low risk, as it's a single dose in healthy volunteers, there are always potential risks with any medication, such as mild side effects. These would be fully explained before you agree to take part. 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
Bulgaria

Common questions

What is cladribine?

Cladribine is a medicine used to treat certain conditions, but in this study, we are simply comparing two versions of the tablet, not treating any illness.

Why do you need healthy volunteers?

We use healthy volunteers to see exactly how the medicine is absorbed and processed by the body, without other health conditions causing confusion.

What does 'fed conditions' mean?

It means you will take the study medication after you have eaten a meal, as food can sometimes affect how medicines are absorbed.

Will I receive any treatment for an illness?

No, this study is not designed to treat any medical condition. It's purely for research to compare two forms of the medication.

What is a 'bioequivalence' study?

It's a type of study that checks if two different versions of the same medicine act in the body in exactly the same way.