Bioequivalence of Vortioxetine 5 mg Film-Coated Tablets in Healthy Participants Under Fasting Conditions.
This research study is about a medicine called vortioxetine, which is used to treat depression. The study aims to compare a new version of the 5 mg film-coated tablet with the original one. We want to see if the new tablet delivers the medicine into the body in the same way as the original. This is important to ensure the new tablet will be just as safe and effective for patients who need it. We are looking for healthy adults to take part. Volunteers will be asked to take the medicine after not eating (fasting). This type of study, called a bioequivalence study, is a common and necessary step before a new version of a medication can be made available.
At a glance
What is this study about?
This research study is a type of investigation where we look closely at how a medicine behaves in the human body. In this case, we're focusing on a medication called vortioxetine, which is prescribed for depression. When a company wants to make a new version of an existing medicine, like a generic tablet, they need to prove it works just as well as the original one. That's where studies like this come in.
The main goal is to compare a new 5-milligram (mg) tablet of vortioxetine with the original 5 mg tablet. We want to see if both tablets release the drug into your bloodstream at the same speed and to the same extent. Think of it like comparing two different brands of bottled water – you want to make sure they're both giving you the same amount of water, even if the bottles look a little different. This is called a 'bioequivalence' study.
By doing this, doctors and regulators can be confident that the new version of the medicine will be just as safe and effective for patients who need it. This research is a crucial step in making sure that patients have access to reliable medications. It helps ensure that new versions of drugs perform as expected, providing the same benefits as the original product.
Key takeaways
- Compares a new form of vortioxetine (antidepressant) with the original.
- Aims to prove the new tablet works just as well in the body.
- Looking for healthy adult volunteers, aged 18 and over.
- Involves taking the medicine and giving blood samples while fasting.
- Contributes to ensuring new medicines are safe and effective.
- Participation will be carefully explained, and your rights protected.
Who may be eligible?
This study is looking for healthy adult volunteers. You will be generally well and will not have any specific medical conditions or illnesses. Both men and women are welcome to take part.
To be considered, you need to be at least 18 years old. There is no upper age limit, meaning that adults of any age from 18 upwards can potentially join. The most important thing is that you are healthy, as this study is designed to see how the medicine works in a typical, healthy body.
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 well?
- Do you have no ongoing medical conditions or serious illnesses?
- Are you comfortable with abstaining from food for a period (fasting)?
- Are you willing to give blood samples regularly during study visits?
What does participation involve?
Taking part in this study would involve a few visits to a special research clinic. During these visits, you would be asked to take a dose of the study medicine, usually after a period of not eating (fasting). Nurses or doctors would then take several blood samples from you over a period of time. This is to measure how much of the medicine is in your blood and how quickly it gets there and leaves your body.
You would receive both the new version of the medicine and the original version during the study, though not at the same time. The total length of your participation, including all visits and follow-up, would be explained fully before you decide to join. You would be closely monitored by medical staff throughout your time in the study.
Potential risks and benefits
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Common questions
What is vortioxetine used for?
Vortioxetine is a medicine prescribed by doctors to help people with depression.
Why is this study needed if the medicine already exists?
This study checks if a new version of the tablet works the same way as the original. This is important to make sure it's just as effective and safe.
Will I get the actual medicine used for depression treatment?
Yes, you would receive the 5 mg tablets of vortioxetine, but not for treating depression. It's to see how the drug performs in your body.
Will I have to fast before taking the medicine?
Yes, for part of the study, you would be asked not to eat for a certain period before taking the medicine. This helps ensure consistent results.
Do I need to be ill to join this study?
No, quite the opposite! This study is specifically looking for healthy volunteers who do not have any medical conditions.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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