Comparative Bioavailability of Teriflunomide 14 mg Film-Coated Tablets: A Single-Dose, Open-Label, Randomized, Two-Sequence, Two-Treatment, Two-Period Crossover Study in Healthy Subjects Under Fasting Conditions.
This research is looking at how a 14mg tablet of a medicine called teriflunomide is absorbed by the body. This study is being done on healthy men, meaning people who don't have any medical conditions. The main goal is to find out if a new version of the teriflunomide tablet acts the same way as an already approved one. This is important to make sure that any changes to how a medicine is made don't affect how well it works. Participants will take the medicine once, and doctors will carefully measure how much of it gets into their blood. This helps ensure that patients eventually receive medicine that is reliable and effective.
At a glance
What is this study about?
This study is about a medicine called teriflunomide, which is already used for certain conditions. When a medicine company makes a small change to how a tablet is manufactured, or creates a new version, they need to check if the body absorbs it in the same way as the original. This is extremely important to make sure the medicine continues to work properly and safely for patients.
In this particular study, researchers are giving a single dose of teriflunomide 14mg tablets to healthy male volunteers. They will then closely monitor how the medicine is absorbed into the bloodstream. This process is called a "bioequivalence study," which simply means they are comparing if two different forms of the same medicine act the same way in the body.
The findings from this type of study help regulatory bodies, like the UK's Medicines and Healthcare products Regulatory Agency (MHRA), ensure that all approved medicines are consistent. It helps guarantee that if you switch from one manufacturer's version of a medicine to another, it will have the same effect. It's a crucial step in ensuring medication safety and effectiveness for everyone.
Key takeaways
- This study compares how two versions of teriflunomide 14mg tablets are absorbed.
- It involves healthy adult men aged 18 and over.
- Participation involves taking a single dose of the medicine on two occasions after fasting.
- Blood samples will be taken regularly to measure medicine levels.
- The study helps ensure medicines are consistently safe and effective.
- You can withdraw from the study at any time.
Who may be eligible?
This study is looking primarily for healthy men to take part. Being healthy means you generally don't have any ongoing medical conditions that might affect how your body handles the study medicine.
You would need to be at least 18 years old to participate. There isn't an upper age limit mentioned, but you would still need to meet all the health requirements. The study is specifically for men.
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 a man?
- Are you 18 years old or older?
- Are you generally healthy with no ongoing medical conditions?
- Are you willing to fast before taking medicine and provide blood samples?
What does participation involve?
If you decide to take part in this study, you would first go through a screening visit to check if you are healthy and meet all the study requirements. If you qualify, you would take the study medicine (teriflunomide 14mg) on two separate occasions, with a break in between. On these dosing days, you would likely spend a significant amount of time at the study clinic, as blood samples would be taken regularly to measure the medicine's levels in your body.
You will be asked to fast before taking the medicine, meaning you won't eat for a certain period. The total time you'd be involved in the study, including all visits and follow-up, would be fully explained to you before you agree to participate. You will receive detailed instructions about what you can and cannot do during your time in the study.
Potential risks and benefits
Locations (1)
- —UnverifiedPortugal
Common questions
What is teriflunomide for?
Teriflunomide is a medicine used to treat conditions like multiple sclerosis. This study isn't testing its effect on a disease, but rather how it's absorbed by the body.
Why is this study only for men?
Studies sometimes focus on a specific group, like men, to simplify the data collection without other factors affecting the results. This is common in early-stage trials comparing how a drug is absorbed.
Will I get money for taking part?
Many clinical studies offer some payment for your time, travel, and inconvenience. This is something the study team will discuss with you if you are interested.
Will I have to stay overnight at the clinic?
While the detailed description isn't available, studies that involve frequent blood sampling often require overnight stays or long periods at the clinic on dosing days. This will be made clear to you.
Are there any long-term follow-up visits?
After the main study visits, there might be a final follow-up visit or phone call to ensure you are well. The study team will provide all these details upfront.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.