An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Ruxolitinib Tablets, 20 mg, manufactured by Sun Pharmaceutical Industries Limited, India with JAKAVI (ruxolitinib) tablets 20 mg, (each Jakavi 20 mg tablet contains 26.40 mg of ruxolitinib phosphate equivalent to 20 mg of ruxolitinib). Imported by: Novartis Biociências SA Av. Prof. Vicente Rao, 90 - São Paulo - SP CNPJ: 56.994.502/0001-30. Manufactured by: Novartis Pharma Stein AG, Stein – Switzerland, in healthy adult, human subjects under fasting condition.
This research is looking at a new 20mg ruxolitinib tablet made by Sun Pharmaceutical Industries Limited. We're comparing it to the existing Jakavi 20mg ruxolitinib tablet. The main goal is to find out if the new tablet works in the human body in the same way as the current one. This is called a 'bioequivalence' study. Healthy adult volunteers will take both tablets at different times, on an empty stomach. This kind of study is important because it helps scientists understand if a new version of a medicine will be just as safe and effective as the original, without having to test it on people who are unwell. This ensures that when new medicines become available, they will work as expected.
At a glance
What is this study about?
This research is a 'bioequivalence' study, which is a common and important step when a new company wants to make a version of an existing medicine, like the drug ruxolitinib. Ruxolitinib is a medicine used to treat conditions such as myelofibrosis (a bone marrow disorder), polycythemia vera (a blood disorder), and graft-versus-host disease (a complication after stem cell transplants).
The study aims to compare a new 20mg ruxolitinib tablet made by Sun Pharmaceutical Industries, an Indian company, with the existing 20mg Jakavi tablet, which is made by Novartis in Switzerland. The main question scientists want to answer is: does the new tablet behave in exactly the same way in the body as the original Jakavi tablet?
To find this out, healthy adult volunteers will participate. They will take a single dose of each tablet at different times, on an empty stomach. Researchers will then measure how much of the drug gets into the body and how quickly. If the new tablet delivers the medicine to the body in a very similar way to the original, it means it's likely to be just as safe and effective. This type of study helps make sure that when new versions of important medications become available, they will work just as well as the original to help patients.
Key takeaways
- This study compares a new version of ruxolitinib with the existing one.
- It aims to ensure the new tablet works in the body in the same way as the original.
- Healthy adults aged 18 and over can take part.
- Participants will try both tablets, one at a time, on an empty stomach.
- Blood samples will be taken to see how the body uses the medicine.
- Taking part helps advance medical knowledge and ensures safe new medicines.
Who may be eligible?
To join this study, you need to be a healthy adult aged 18 or older. Both men and women are welcome to take part. Being 'healthy' means you don't have any major ongoing health problems that could affect the study results or make your participation unsafe.
The study is specifically looking for healthy people, not those with the conditions ruxolitinib is usually prescribed for. This is because we want to see how the drug acts in a healthy body before making assumptions about how it works in people who are unwell.
There might be other health checks or requirements that the study team will discuss with you. These are in place to make sure the study is safe for you and that the results collected are accurate and reliable.
- Are you 18 years old or older?
- Are you generally in good health?
- Are you comfortable having regular blood tests?
- Are you willing to fast (not eat or drink) before and after taking medication?
- Are you able to commit to the required clinic visits?
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 a single dose of one of the ruxolitinib tablets (either the new one or the existing one) on an empty stomach. At a later time, during a separate visit, you will then be given a single dose of the other tablet, also on an empty stomach. This is called a 'crossover' study, so you get to try both.
During your visits, doctors and nurses will take blood samples regularly to measure how your body processes the medicine. They'll also monitor you for any effects or side effects. The study involves a few visits to the clinic, and each visit might involve spending several hours there. The total duration of your participation, from your first visit to your last follow-up, will be clearly explained by the study team.
Potential risks and benefits
Locations (1)
- —Romania
Common questions
What is ruxolitinib used for normally?
Ruxolitinib is a medicine used to treat certain blood and bone marrow disorders, like myelofibrosis and polycythemia vera, and also a condition called graft-versus-host-disease after transplants.
Why use healthy people for this study?
Using healthy volunteers helps researchers understand how the medicine behaves in the body without other health conditions affecting the results, making it clearer to compare the two tablets.
What does 'fasting condition' mean?
It means you won't be allowed to eat or drink anything (except water) for a certain number of hours before taking the medicine and for a short time afterwards, as food can change how your body absorbs the drug.
Will I know which tablet I'm taking first?
This is an 'open label' study, which means you and the researchers will know which tablet you are taking at each stage.
Will I get paid for taking part?
Often, these types of studies offer some payment to volunteers for their time and to cover travel expenses. The study team will give you full details on this.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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