An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study comparing Deucravacitinib tablets 6 mg, Manufactured by Sun Pharmaceutical Industries Limited, India with SOTYKTU (deucravacitinib) tablets 6 mg, Distributed by Bristol-Myers Squibb Company, Princeton, New Jersey 08543 USA, in healthy, adult, human subjects under fasting condition.
This research study is looking at two different versions of a medicine called deucravacitinib, which is used to treat a skin condition called plaque psoriasis. One version is the original, and the other is a new, similar version (often called a generic). The main goal is to check if these two medicines work in exactly the same way in the body. This is called a 'bioequivalence' study. Healthy adults will take both medicines, one at a time, to see how their bodies handle each one. This helps scientists confirm that the new version is just as effective and safe as the original. It's an important step before a new medicine can be made widely available, ensuring patients get consistent treatment.
At a glance
What is this study about?
Imagine you have a key, and a locksmith makes a copy. You expect the copy to open the lock just as well as the original. This study is doing something similar, but with medicine! We're comparing two versions of a drug called deucravacitinib. This medicine is used to treat a skin condition called plaque psoriasis, which causes red, scaly patches on the skin.
One version of the medicine is already available (the 'original' key), and the other is a new version made by a different company (the 'copy' key). For the new version to be approved for use, we need to make sure it acts exactly the same way in the body as the original. This process is called a 'bioequivalence' study, which simply means we're checking if they're equally effective and absorbed.
By carefully comparing how healthy people's bodies handle each medicine, scientists can confirm if the new version is just as good as the original. This is a crucial step to ensure that if the new version becomes available, patients with plaque psoriasis can be confident that they are receiving the same safe and effective treatment.
Key takeaways
- Compares two versions of a psoriasis medicine.
- Aims to prove a new version works the same as the original.
- Involves healthy adults, both men and women.
- You'll take both medicines at different times.
- Helps make new medicines safely available.
- Participation involves clinic visits and blood tests.
Who may be eligible?
This study is looking for healthy adults. You must be at least 18 years old to take part. There is no upper age limit, meaning people of all adult ages can be considered.
Both men and women are welcome to participate in this research. The study needs a mix of people to get a complete picture of how the medicines work.
Crucially, this study is for healthy people, not those actively experiencing plaque psoriasis. This allows researchers to focus purely on how the body absorbs and processes each medicine without other health conditions making the results unclear.
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, without any major ongoing medical conditions?
- Are you able to follow study instructions carefully?
- Are you comfortable with blood tests?
- Are you willing to fast before taking study medication?
- Are you able to commit to several clinic visits?
What does participation involve?
If you decide to take part, you'll visit the study clinic multiple times. You’ll be given one of the deucravacitinib medicines first, and then after a break, you'll receive the other medicine. This is so we can compare how your body reacts to both. You'll switch between the two medicines during the study, often called a 'crossover' design. Each time you take a medicine, blood samples will be taken over several hours to see how the drug levels change in your body. You'll likely need to fast (not eat) before taking the medicine. The total time you'll be involved in the study, from your first visit to your last, will be explained in detail by the study team.
Potential risks and benefits
Locations (1)
- —UnverifiedRomania
Common questions
What is 'plaque psoriasis'?
Plaque psoriasis is a common skin condition that causes red, flaky, crusty patches covered with silvery scales. It's not contagious.
Why is this study only for healthy people?
Healthy volunteers help researchers understand exactly how a new medicine is absorbed and processed by the body, without other health problems affecting the results.
What does 'bioequivalence' mean?
It means the study is checking if two different versions of the same medicine work in exactly the same way in the body. Are they equally effective and safe?
Will I get money for taking part?
Many clinical studies offer some payment or reimbursement for your time, travel, and inconvenience. You should ask the study team about this.
What does 'fasting condition' mean?
It means you will be asked not to eat or drink anything (other than water) for a certain period before taking the study medicine, usually overnight, to ensure accurate results.
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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