An open label, balanced, randomized, two-treatment, four period, two-sequence, multiple-dose (steady-state), fully-replicate crossover bioequivalence study comparing Upadacitinib Prolonged Release Tablets 15 mg, manufactured by Sun Pharmaceutical Industries Limited, India with 15 mg prolonged-release tablets (Upadacitinib), Marketing Authorization Holder: AbbVie Deutschland GmbH & Co. KG Knollstraße 67061 Ludwigshafen Germany, in healthy adult, human subjects under fasting condition.
This research is looking at two different 15mg upadacitinib tablets to see if they are equally absorbed and behave the same way in the body. One tablet is already available, and the other is a new version made by a different company. This type of study, called a bioequivalence study, helps ensure that patients receive the same treatment effect, regardless of which version of the medicine they take. It's being conducted in healthy adult volunteers and is an early-stage study, meaning it's about understanding how the drug works in the body, rather than treating any illnesses. The original version of upadacitinib is used for conditions such as rheumatoid arthritis, ulcerative colitis, and Crohn's disease.
At a glance
What is this study about?
This study is comparing two types of a medicine called upadacitinib, both at a 15mg dose. Upadacitinib is a drug used to treat several long-term conditions like rheumatoid arthritis, which causes joint pain and swelling, and Crohn's disease, which affects the digestive system. It's also used for conditions like ulcerative colitis, atopic dermatitis (eczema), and psoriatic arthritis.
The main goal of the study is to see if a new version of the 15mg upadacitinib tablet works in the human body in the same way as the original, already approved version. This is called a 'bioequivalence' study. It's important because it makes sure that if you take the new tablet, your body will process it in exactly the same way as the original, meaning you'll get the same benefits from the medication. This ensures that new versions of drugs are just as effective and safe as the ones already in use.
Because this is an early-stage study, it's being conducted with healthy adults, not people who have these conditions. This helps researchers understand the basic way the drug behaves in the body without other health issues potentially complicating the results. The 'prolonged release' part means the medicine is designed to release slowly over time, giving a more steady effect.
Key takeaways
- This study compares two versions of upadacitinib 15mg tablets.
- It aims to confirm that a new tablet works exactly like an existing one.
- Only healthy adults aged 18 and over can participate.
- You'll take both tablets at different times and have blood tests.
- The study helps ensure new medications are effective and safe.
Who may be eligible?
To join this study, you need to be a healthy adult aged 18 or older. The study is open to both men and women.
Since this is an early-stage study to understand how the medicine works in the body, it's important that participants do not have any existing health conditions that would interfere with the study results. People with rheumatoid arthritis, ulcerative colitis, atopic dermatitis, Crohn's disease, or other significant illnesses would not be able to join this particular study.
Specific medical checks will be done during the screening process to make sure you are healthy enough to take part and that the study would be safe for you.
- Are you 18 years old or older?
- Are you generally in good health?
- Do you *not* have rheumatoid arthritis, Crohn's disease, or similar conditions?
- Are you able to follow study instructions, including fasting for periods?
- Are you able to commit to several clinic visits over weeks or months?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you will be given both versions of the upadacitinib tablet at different times throughout the study. This study is designed to compare how your body handles both medications when you haven't eaten (fasting condition). You'll visit the study clinic several times over a period. Each visit will involve taking the study medication, and then having blood samples taken regularly to measure how much of the drug is in your body over time. You will also have health checks, like blood pressure and heart rate measurements, at each visit. The study uses a 'crossover' design, meaning you will receive one type of tablet, then after a period of time, you will receive the other. This helps compare the two tablets within the same person. The total duration of your involvement, including all visits and follow-up, will be explained in detail.
Potential risks and benefits
Locations (1)
- —Romania
Common questions
What is upadacitinib used for normally?
Upadacitinib is typically used to treat various inflammatory conditions like rheumatoid arthritis, Crohn's disease, ulcerative colitis, atopic dermatitis (eczema), and psoriatic arthritis.
Why are you testing healthy people if the drug is for illnesses?
Early studies like this are done in healthy people to understand how the drug is absorbed and processed by the body, ensuring the tests aren't complicated by existing health conditions.
What does 'prolonged release' mean?
It means the tablet is designed to release the medicine slowly into your body over many hours, rather than all at once, to provide a more steady effect.
Will I know which tablet I am taking?
The study design is 'open label,' which means both you and the study team will know which tablet you are receiving at any given time.
What does 'fasting condition' mean?
It means you will need to take the study medication on an empty stomach, usually after not eating for a certain number of hours, to ensure consistent results.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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