An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Upadacitinib Prolonged Release Tablets 15 mg, manufactured by Sun Pharmaceutical Industries Limited, India with RINVOQ 15 mg prolonged-release tablets (Upadacitinib), Marketing Authorization Holder: AbbVie Deutschland GmbH & Co. KG Knollstraße 67061 Ludwigshafen Germany, in healthy adult, human subjects under fed condition.
This research study is about a medicine called upadacitinib, which is used to treat conditions like arthritis and inflammatory bowel diseases. We are comparing a new generic version of upadacitinib made by Sun Pharmaceutical Industries with the original Rinvoq medicine. The main goal is to see if these two versions are absorbed by the body in the same way when taken by healthy adults after a meal. This is called a bioequivalence study. Participants will take each medicine at different times and have their blood checked to make sure the new version works just as well as the original. This type of study helps ensure that new generic medications are safe and effective alternatives.
At a glance
What is this study about?
This study is looking at a medicine called upadacitinib. This medicine is prescribed for several conditions, including different types of arthritis (like rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis), and inflammatory bowel diseases like Crohn’s disease and ulcerative colitis. It's also used for severe skin conditions such as atopic dermatitis.
The main purpose of this study is to compare two different versions of upadacitinib. One is the original medicine, sold under the brand name Rinvoq, and the other is a new version made by Sun Pharmaceutical Industries. Both are prolonged-release tablets, meaning the medicine is released slowly into your body over time.
Researchers want to make sure that the new version works just as effectively as the original Rinvoq. To do this, they’ll give both medicines to healthy volunteers and measure how much of the medicine gets into their bloodstream and how quickly. This is crucial for making sure that once the new medicine is available, it will have the same benefits and safety profile as the original.
Key takeaways
- Compares two versions of upadacitinib medicine.
- Tests how the medicine acts in healthy adults.
- Aims to ensure new generic medicines are equally effective.
- Involves multiple clinic visits and blood tests.
- Participation helps advance medical understanding.
Who may be eligible?
To join this study, participants need to be healthy adults. This means you should be 18 years old or older, and there is no upper age limit, as long as you are considered generally healthy by the study doctors.
Both men and women are welcome to take part in this research.
Since this is an early-stage study that tests the medicine in healthy people, specific health conditions that upadacitinib is meant to treat (like arthritis or Crohn's disease) would mean you couldn’t join. The study focuses on how the medicine acts in a healthy body.
- Are you 18 years old or older?
- Do you consider yourself generally healthy?
- Are you able to attend several clinic visits?
- Are you comfortable with regular blood tests?
- Do you not have any of the medical conditions upadacitinib usually treats?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you take part in this study, you will visit the clinic multiple times. You will be given one of the two upadacitinib medicines to take after eating a meal. Then, after a break (called a 'washout period') to allow the first medicine to leave your body, you will repeat the process with the other upadacitinib medicine.
During each visit after taking the medicine, you will have blood samples taken regularly over several hours. These blood tests will help the doctors measure how the medicine is absorbed and processed by your body. The entire study involves a few clinic visits and can last for several weeks, including the time between taking the two different medicines.
Potential risks and benefits
Locations (1)
- —Romania
Common questions
What is upadacitinib?
Upadacitinib is a medicine used to treat conditions like different types of arthritis and certain inflammatory bowel diseases.
Why is this study being done?
This study is comparing a new version of upadacitinib with the original to make sure they work the same way in the body.
Does this study test the medicine in patients with a disease?
No, this study is done in healthy adult volunteers, not in people with the conditions the medicine usually treats.
What does 'fed condition' mean?
It means you will take the medicine after you have eaten a meal, as directed by the study team.
Will I have to stay overnight at a clinic?
The information provided doesn't specify, but studies often require clinic visits spanning many hours or overnight stays for frequent blood sampling.
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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