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 fasting condition.
This study is looking at two versions of a medicine called upadacitinib. One is a new version made by Sun Pharmaceutical Industries Limited, and the other is the existing RINVOQ drug. The main goal is to find out if the new version works in the body in the exact same way as RINVOQ. This is called a 'bioequivalence' study. They will give a single dose of each drug to healthy adult volunteers at different times to see how the body absorbs and uses them. This type of study is important to make sure new medicines are just as effective and safe as existing ones for conditions like rheumatoid arthritis or Crohn's disease, even though the volunteers in this study are healthy.
At a glance
What is this study about?
This study is a type of research called a "bioequivalence" study. Imagine you have two identical glasses, and you pour the same amount of water into both. A bioequivalence study checks if two different versions of the same medicine act like that water – reaching the same level in your body at the same time and staying there for the same duration. In this case, researchers are comparing a new tablet of a drug called upadacitinib, made by a company called Sun Pharmaceutical, with the existing RINVOQ tablet, which also contains upadacitinib.
The main purpose is to make sure that the new version of the upadacitinib tablet is just as effective and safe as the well-known RINVOQ tablet. They want to see if your body absorbs the new tablet in the exact same way as RINVOQ and if it reaches similar levels in your blood. This is important because upadacitinib is used to treat serious conditions like rheumatoid arthritis, ulcerative colitis, and other inflammatory diseases. If a new version works the same, it means patients can switch between them without any difference in how well the medicine works.
To do this, healthy adult volunteers will take a single dose of each medicine at different times. By looking at how the drug levels change in their blood, the researchers can figure out if the two versions of the drug are truly alike. This type of study, often called a Phase I study, is a very important first step in developing new medicines, even though the volunteers don't have the conditions the drug usually treats.
Key takeaways
- Compares two versions of the upadacitinib drug (RINVOQ).
- Aims to check if a new version works the same as the original.
- Healthy adult volunteers are needed for this study.
- Involves taking a single dose of each drug at different times.
- Blood samples will be taken to measure drug levels in the body.
- Contributes to ensuring new drugs are safe and effective.
Who may be eligible?
To join this study, you need to be a healthy adult aged 18 or over. This study is open to both men and women.
Because this study is looking at how the medicine works in the body of healthy people, you won't be able to join if you have any serious long-term health conditions. The researchers want to make sure that any measurements they take are purely about how your body handles the drug, rather than being affected by other illnesses.
There will be other detailed health checks to make sure you are suitable and able to take part safely. It's important to remember that even if you meet these general criteria, the full screening process will determine if you are a good fit.
- Are you 18 years old or older?
- Are you generally in good health?
- Are you willing to follow specific study instructions, like fasting?
- Are you comfortable with regular blood tests?
- Are you available for multiple visits to a study clinic?
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 would visit the study clinic multiple times. During these visits, you would be given a single dose of one of the upadacitinib tablets. After taking the medicine, a team of doctors and nurses will closely monitor you. They will take blood samples at specific times to measure how much of the drug is in your body and how it's being processed. You would also have regular health checks, vital sign measurements, and possibly other tests to ensure your safety and that the medicine isn't causing any problems. After a break (called a wash-out period), you would return to the clinic to receive the other version of the upadacitinib tablet, and the process of monitoring and blood sampling would be repeated. The total duration of your involvement, including all visits and breaks between doses, would be explained to you in detail by the study team.
Potential risks and benefits
Locations (1)
- —Romania
Common questions
What is upadacitinib normally used for?
Upadacitinib (RINVOQ) is a medicine used to treat conditions like rheumatoid arthritis, ulcerative colitis, Crohn's disease, and certain skin or spine conditions where the body's immune system is overactive.
Why are healthy people needed for this type of study?
Healthy volunteers are needed to get a clear picture of how the body handles the drug without other illnesses affecting the results. This helps researchers understand the basic way the drug behaves.
What does 'fasting condition' mean for the study?
Fasting means you will need to stop eating and drinking (except for water) for a certain number of hours before you take the medicine in the study. This ensures your body absorbs the medicine consistently.
Will I know which drug I'm taking first?
Because it's a 'crossover' study, you will eventually take both versions of the drug. However, the order in which you receive them will be determined by chance, like flipping a coin, and you might not know which one you are getting at each specific visit.
Is this a new medicine that hasn't been approved yet?
No, upadacitinib (RINVOQ) is an approved medicine. This study is comparing a new version or generic form of it to the original, to ensure they work in the same way.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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