Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence clinical trial of two formulations of vortioxetine.

This research is a 'bioequivalence' study, which means scientists are comparing two different versions of the same medicine, called vortioxetine. The main goal is to find out if both versions are absorbed into your body in the same way and at the same speed. This is important to make sure that new medicines work just as well as existing ones. The study is for healthy adult volunteers, aged 18 and older, and can include both men and women. It's an early phase of testing, focusing on understanding how the drug behaves in the human body rather than treating a specific illness. This kind of study helps ensure that any new generic versions of medicines are just as effective and safe as the original.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Normon S.A.

Enrolment target

Start

20 Dec 2024

Healthy volunteers

What is this study about?

This study is focused on a medicine called vortioxetine. We're looking at two different versions of this medicine to see if they are absorbed by your body in the same way and at the same speed. Think of it like comparing two different brands of the same common painkiller; even though they have the same active ingredient, scientists need to make sure your body uses them in an identical fashion.

This kind of research is called a 'bioequivalence' study. It's a very important step when a new version of an existing medicine is being developed. The goal is to prove that the new version works just as well as the original, meaning it delivers the active drug to your bloodstream in the same amount and at the same rate. This helps ensure that patients can switch between different versions of a medicine, such as a new generic brand, without any change in how well it treats their condition.

Because we are mainly looking at how the medicine is absorbed and processed by the body, this study is recruiting healthy volunteers. You don't need to have a particular illness to take part. It's an early stage of medication development, and the information we gather here is vital for making sure all future versions of vortioxetine are safe and effective for everyone who needs them.

Key takeaways

This study compares two versions of vortioxetine to ensure they act the same in the body.
It's for healthy adults aged 18 and over, both men and women.
The main goal is to understand how the medicine is absorbed, not to treat an illness.
Participation involves clinic visits, taking medicine, and blood tests.
You won't directly benefit from the medicine, but you'll contribute to important research.
You can withdraw from the study at any time without penalty.

Who may be eligible?

To be considered for this study, you need to be a healthy adult aged 18 or older. Both men and women are welcome to take part.

Because this study is about how a medicine is absorbed, it's really important that you are generally well and don't have any serious health problems that might affect how your body handles the medicine. This helps the researchers get clear results about the medicine itself, without other health conditions making things complicated.

Specific details about your health will be checked by the study team. They will ask questions about your medical history and do some tests to make sure that taking part is safe for you and that you meet all the necessary requirements 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.

Are you 18 years old or older?
Are you generally in good health?
Are you able to attend study visits as required?
Are you comfortable with having blood samples taken?
Do you understand that you won't be treated for any illness in this study?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will likely need to make several visits to the study clinic. During these visits, you will be given the medicine (one of the two versions being tested). Researchers will then regularly take small blood samples to measure how much of the medicine is in your body and how quickly it's being processed. You might also have other check-ups like blood pressure readings or heart rate monitoring.

Participation usually involves staying at the clinic for a short period after taking the medicine, especially after the first dose. There may be a 'washout' period between taking the two different versions of the medicine, meaning you'll have a break before receiving the second version. The total duration of your involvement could range from a few days to a few weeks, depending on the study design, including follow-up appointments.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might not directly benefit from taking part, as this study is mainly to help develop new medicines for the future. However, you will receive health check-ups and contribute to medical research. Potential risks might include mild side effects from the medication, discomfort from blood tests, or a small chance of an allergic reaction. All procedures will be carefully explained, and your safety is the top priority. 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
Spain

Common questions

What is vortioxetine for?

Vortioxetine is a medicine typically used to help with depression. This study is not treating depression, but rather checking how different versions of the medicine work in the body.

Why use healthy volunteers?

Using healthy volunteers helps researchers understand exactly how the medicine is absorbed and processed by the body without other health conditions getting in the way or affecting the results.

Will I know which version of the medicine I'm taking?

Often in these types of studies, participants don't know which version of the medicine they are taking to avoid affecting the results. This is called 'blinding'.

Will I get paid for taking part?

Many clinical trials offer some payment for your time and inconvenience. This will be discussed in detail by the study team if you express interest.

What's the difference between Phase I and a bioequivalence study?

Phase I trials are the first time a drug is tested in humans, focusing on safety and how the body handles the drug. A bioequivalence study is a type of Phase I study that specifically compares two versions of a drug to see if they are the same in how the body absorbs them.