Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence of Lenvatinib 10 mg Capsules versus Lenvima® 10 mg Capsules in Healthy Participants Under Fasting Conditions.

This research study is for healthy adults and is focused on a medication called Lenvima, which is used to treat certain types of cancer. The study aims to find out if a new version of the Lenvima 10 mg capsule works in exactly the same way as the original Lenvima 10 mg capsule. This is called a 'bioequivalence' study. Essentially, it checks if the body absorbs and uses the new capsule in the same amount and at the same speed as the original. This is an important step to ensure that any new version of a medication is just as effective and safe as the one doctors already prescribe.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Bluepharma Industria Farmaceutica S.A.

Enrolment target

Start

19 Jun 2024

No medical condition.

What is this study about?

This study is about a medicine called Lenvima, which is used to treat some cancers. When a company wants to make a new version of an existing medicine, they need to show that it works just as well as the original. This is often done by checking if the new version delivers the same amount of the active drug to your body, and at the same rate, as the original medicine. This type of study is called a 'bioequivalence' study.

In this particular study, researchers are comparing a new 10 mg Lenvatinib capsule with the original Lenvima 10 mg capsule. They want to see if your body handles both capsules in the same way. This is important to make sure that if this new capsule becomes available, patients will get the same benefits as they would from the current Lenvima.

This kind of study is usually done in healthy volunteers because it helps scientists understand how the drug is absorbed and processed by the body without being affected by an existing illness. It's a key step in developing new medicines or new versions of existing ones, making sure they are reliable and safe for patients who need them.

Key takeaways

This study compares a new version of a cancer drug (Lenvatinib) with the original (Lenvima).
It's about checking if both capsules deliver the same amount of medicine to the body.
Healthy adults (18 and over) are needed to participate.
Participation involves taking the medicine while fasting and having blood samples taken.
This research helps make sure new medicines or versions are safe and work well.

Who may be eligible?

This study is looking for healthy adults to take part. To be considered, you must be at least 18 years old. There's no upper age limit mentioned, so older adults can also be considered.

Researchers are looking for both men and women to participate. The important thing is that you should not have any medical conditions, as this study is specifically designed for healthy people to see how the medication works in a typical body.

More detailed checks will be done by the study team, such as looking at your medical history and doing some health examinations, to make sure it's safe for you to take part and that you meet all the necessary requirements.

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 and have no serious medical conditions?
Are you comfortable with taking medication and having blood tests?
Are you able to attend several appointments over a short period?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the new Lenvatinib capsule or the original Lenvima capsule. You won't know which one you're taking at any given time, nor will the study team. You'll take the medicine under fasting conditions, meaning you won't have eaten for a certain period before taking it.

To see how your body handles the medicine, you'll need to attend several appointments where blood samples will be taken at specific times. These samples help researchers measure how much of the drug is in your bloodstream over time. You might also have other checks, such as blood pressure and heart rate measurements, to monitor your health.

This study is a short-term commitment, often involving a stay at a clinic for a day or two for each dose, followed by outpatient visits. The total duration of your involvement, including all visits and follow-ups, will be clearly explained to you by the study team before you agree to take part.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. For this study, potential benefits might include contributing to important medical research that helps bring new and reliable medicines to patients. You'll also receive careful medical monitoring during your participation. Potential risks could include side effects from the medication, even though it's a known drug, or discomfort from blood draws. You will be fully informed of all known and potential risks before you decide to join. Remember, you can choose 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 does 'bioequivalence' mean?

It means the study is checking if a new version of a medicine works in exactly the same way as the original, delivering the same amount of drug to your body at the same speed.

Why are healthy people taking part in a study about a cancer drug?

Studies in healthy volunteers help researchers understand how the body processes the drug without other illnesses affecting the results. This is a common and important step in drug development.

Will I know if I'm taking the new or original capsule?

No, this is a 'blinded' study, meaning neither you nor the study team will know which capsule you are receiving. This helps make the study results more reliable.

What happens if I feel unwell during the study?

The study team will monitor you closely. If you feel unwell, you should tell them immediately. Your safety is their top priority, and you can stop participating at any time.

Will I be paid for taking part?

Many studies offer payment or cover travel costs for your time and inconvenience. The study team will tell you about any compensation available.