Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence of Vortioxetine 20 mg Film-Coated Tablets in Healthy Participants Under Fasting Conditions

This research is looking at a new version of a tablet for depression called vortioxetine (20 mg). It's a type of study called 'bioequivalence,' which means we want to check if the new tablet acts the same way in your body as the original, approved version. We need healthy people to take part. Participants will take a single dose of the medicine on an empty stomach. By comparing how the new tablet is absorbed and processed, we can make sure it's just as effective and safe as the original. This is a very common and important step when new versions of medicines are made available.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Cinfa S.A.

Enrolment target

Start

03 May 2024

No medical condition

What is this study about?

This study is about a new version of a common medicine called vortioxetine. Vortioxetine is used to help people with depression. Before a new version of a medicine can be used, researchers need to make sure it works in exactly the same way as the original. This is like comparing two identical cars from different factories – you want to make sure they both drive the same.

In this study, researchers will give healthy volunteers a single tablet of the new vortioxetine medicine on an empty stomach. They will then take blood samples over time to see how the medicine is absorbed into the bloodstream. This helps them understand if the new tablet delivers the medicine to your body in the same way as the original.

Studies like this are called 'bioequivalence' studies. They are very important because they help ensure that new, often cheaper, versions of medicines are just as safe and effective as the branded ones you might already know. This means that doctors can confidently prescribe them, and patients can be sure they are getting the same treatment.

Key takeaways

This study tests a new version of a depression medicine called vortioxetine.
It helps ensure the new tablet works just like the original one.
Healthy adultos (18+) are needed to take part.
You will take a single tablet on an empty stomach.
Blood samples will be taken to see how the medicine is absorbed.
Your participation helps make new medicines safely available.

Who may be eligible?

To take part in this study, you need to be a healthy adult aged 18 or older. "Healthy" means you don't have any major medical conditions, and you're generally well.

Because we're testing a medicine, there will be checks to make sure your body is working properly, like blood tests. If you have any ongoing health problems or take regular medication, this study might not be right for you.

Both men and women can take part. The research team will do a thorough health check 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 healthy with no known major long-term illnesses?
Are you able to follow study instructions, including fasting?
Are you comfortable with having regular blood samples taken?
Do you not take any regular medication that could interfere with the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you won't have a medical condition. You'll be asked to visit the study clinic a few times. During these visits, you'll take a single 20 mg vortioxetine tablet on an empty stomach. This means you won't have eaten anything for a certain period before taking the medicine. The research team will then take regular blood samples to measure how the medicine is processed by your body. There might be other checks, like measuring your heart rate or blood pressure.

Each visit will have a specific schedule, and you'll need to stay at the clinic for several hours. There will also be follow-up calls or visits to make sure you're doing well after the medicine has left your system. The total duration of your involvement could range from a few days to a couple of weeks, including screening, dosing, and follow-up.

Potential risks and benefits

Taking part could offer you the benefit of knowing you're helping to bring new medicines to market, potentially helping many people in the future. You may also receive some payment for your time and travel. Potential risks, although generally low in healthy volunteer studies, could include mild side effects from the medication, discomfort from blood tests, or allergic reactions. All potential risks will be fully explained to you before you agree to take part, and your safety will be closely monitored. Remember, you 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 is Vortioxetine used for?

Vortioxetine is a medicine used to treat depression.

Why do you need healthy people for this study?

We need healthy people so we can clearly see how the medicine works in the body without other health issues confusing the results.

Will I get paid for taking part?

Often, healthy volunteer studies offer payment for your time and travel. The research team will provide full details.

What does 'fasting conditions' mean?

It means you won't be allowed to eat or drink anything (except water) for a certain number of hours before and after taking the medicine.

Is this a new medicine that hasn't been tested yet?

No, vortioxetine is an approved medicine. This study is testing if a new version of the tablet works the same way as the original.