Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence of Lenvatinib 10 mg Capsules in Healthy Participants Under Fasting Conditions

This study is looking at a medicine called Lenvatinib, which is already used to treat certain cancers. Researchers want to check if a new version of this medicine works in the same way as the original. They call this 'bioequivalence'. Healthy adult volunteers will take a single dose of the medicine when their stomachs are empty (fasting). The study will then measure how much of the medicine gets into their blood and how long it stays there. This helps ensure that any new version of a medication will be just as effective and safe as the one already available, even if it's made slightly differently.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Bluepharma Industria Farmaceutica S.A.

Enrolment target

Start

07 Jul 2025

No medical condition

What is this study about?

This study is about a medication called Lenvatinib. While Lenvatinib is usually given to people with certain types of cancer, this particular study isn't about treating cancer. Instead, it's a type of very early-stage study, often called a 'Phase I' study, that focuses on how the body handles the medicine.

The main goal is to see if a new version or 'generic' of Lenvatinib acts identically in the body compared to the version that's already approved and used. This is called 'bioequivalence'. Think of it like comparing two different brands of a popular painkiller; you want to make sure they both deliver the same amount of medicine to your system at the same speed, even if they look a little different. This helps health authorities ensure that any new medicine made by a different company will work just as well as the original.

To do this, healthy volunteers will take a single dose of the medicine while they haven't eaten (fasting). Researchers will then take blood samples over a period of time to measure how much of the medicine enters their bloodstream and how long it takes for the body to process it. This information is crucial for making sure that patients who might take this new version of Lenvatinib in the future will get the same consistent and safe treatment as those taking the original.

Key takeaways

This study compares a new version of the cancer drug Lenvatinib with the original.
It's for healthy adults (18 years and older) of any gender.
Participants take a single dose of medication on an empty stomach.
Blood samples will be collected to see how the body handles the medicine.
This research helps ensure new medications are safe and effective.
No direct health benefits for participants, but you contribute to medical knowledge.

Who may be eligible?

This study is looking for healthy volunteers, meaning people who do not have any serious medical conditions. You must be at least 18 years old to take part, and there's no upper age limit, so people of all adult ages are welcome.

Both men and women can participate in this research. The most important thing is that you are generally in good health and not currently taking any other medication that might interfere with the study drug.

Detailed health checks will be carried out by the study team to make sure it's safe for you to take part. This will likely include a medical examination and some blood tests to confirm you are healthy enough for the study.

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.

Am I at least 18 years old?
Am I generally in good health with no serious medical conditions?
Am I willing to fast before taking medication?
Am I comfortable with having blood samples taken several times?
Am I available for the study visits and follow-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive a single dose of the study medicine (Lenvatinib) after a period of not eating, usually overnight. This is known as 'fasting'. After taking the medicine, the study team would need to take several blood samples over a set period to see how your body absorbs and processes the drug. This might involve staying at the research clinic for a day or two. You would then have follow-up visits or contact to check on your well-being. The total duration of your participation would involve the dosing period and any necessary follow-up.

Potential risks and benefits

The main benefit of taking part is contributing to medical science, which helps make sure that new medicines are safe and work correctly for future patients. As this is an early-stage study, there are no direct benefits to your health. Potential risks might include discomfort from blood draws, or experiencing side effects from the Lenvatinib, although healthy people often tolerate it well at single doses. 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 'bioequivalence'?

Bioequivalence means checking if a new medicine works in the same way as an existing one, delivering the same amount of drug to your body at the same speed.

Will this study treat any illness?

No, this study is not designed to treat any illness. It's for healthy volunteers to understand how the medicine is absorbed.

Do I need to be ill to join?

No, quite the opposite! This study specifically needs healthy adult volunteers who don't have any medical conditions.

What does 'fasting conditions' mean?

It means you'll need to go without food for a certain number of hours, usually overnight, before taking the medicine.

Will I be paid to take part?

Sometimes studies offer payment for your time and travel, but this varies. You should ask the study team about this directly.