Randomised, crossover bioequivalence clinical trial of vortioxetine 20 mg film-coated tablets, after a single oral dose administration to healthy volunteers under fasting conditions.
This research is looking at a new version of a common antidepressant medicine called vortioxetine (20mg tablets). We want to make sure this new version is just as good, safe, and effective as the original one you might get from your doctor. We'll do this by giving a single dose of the medicine to healthy volunteers to see how it's absorbed and used by the body. This kind of study helps us understand if the new version works in the same way as the established medicine, ensuring patients get consistent treatment. It's an early-stage study, meaning it's one of the first steps in checking new medicines.
At a glance
What is this study about?
Imagine you have a favourite biscuit, and a new company makes their own version. This study is a bit like that, but for an antidepressant medicine called vortioxetine. We're looking at a new version of the 20mg tablet to see if it behaves exactly the same way in your body as the original version. This is really important because it helps make sure that if you switch from one version to another, you'll get the same benefits and effects from your medicine.
This kind of study is called a 'bioequivalence' study. 'Bio' means life, and 'equivalence' means equal. So, we're checking if the new medicine is biologically equal to the original one. This involves seeing how much of the medicine gets into your bloodstream and how quickly, after you take a single dose.
By doing this research, we help ensure that new versions of existing medicines are reliable and work as expected. This keeps things safe and consistent for patients who rely on these medications to manage their health.
Key takeaways
- This study compares a new version of an antidepressant medicine.
- It aims to ensure the new version works just like the original.
- Healthy adult volunteers (18+) are needed.
- Participation involves taking a single dose and having blood tests.
- Your involvement helps ensure the quality and safety of medicines.
- You can stop participating at any time.
Who may be eligible?
This study is for healthy adults. You must be at least 18 years old to take part. Both men and women are welcome.
To be considered healthy, you shouldn't have any major ongoing medical conditions or be taking medicines that could interfere with the study drug. The research team will do some checks to make sure you're healthy enough to participate.
Unfortunately, if you have certain health problems or are on specific medications, you might not be able to join. The study team will explain all the details to you.
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?
- Do you not have any major ongoing medical conditions?
- Are you not currently taking any medications that might interfere with the study?
What does participation involve?
If you decide to take part, you'll visit the study clinic multiple times. You'll be given a single 20mg tablet of vortioxetine on different occasions, first one type and then the other, with a break in between. You'll need to fast (not eat) before taking the medicine.
During your visits, the research team will take blood samples regularly to see how the medicine is absorbed and cleared by your body. They'll also check your blood pressure, heart rate, and ask about any side effects you might experience. The total duration of your participation, including all visits and follow-ups, will be explained in full detail by the study team.
Potential risks and benefits
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Common questions
What is vortioxetine?
Vortioxetine is a medicine used to help people with depression. This study is looking at a new version of it.
Why do you need healthy volunteers?
For this type of study, using healthy volunteers helps us clearly see how the medicine works in the body without other health conditions affecting the results.
Will I get the actual antidepressant treatment?
You will receive a single dose of the medicine for research purposes, not as an ongoing treatment for any condition.
Will I have to stay overnight?
The study team will tell you if any overnight stays are required for the blood tests and monitoring.
Will I be paid to take part?
Often, studies like this offer some payment for your time and inconvenience. The study team will provide details on this.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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