An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Imatinib Mesylate Tablets 400 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Glivec® (Imatinib mesylate) Coated tablets 400 mg, Produced by Novartis Pharma Produktions GmbH, Wehr, Germany or Novartis Pharmaceutical Manufacturing LLC, Ljubljana; Imported and Registered by Novartis Biosciences SA, Prof. Vicente Rao Avenue, 90, Sao Paulo – SP, CNPJ: 56.994.502/0001-30, Brazilian Industry, in healthy adult, human subjects under fed condition.
This study is looking at a new version of a medicine called imatinib, made by Sun Pharmaceutical Industries. This new tablet has 400mg of imatinib. Researchers want to compare it with the original Glivec 400mg tablet, which also contains imatinib. The main goal is to see if these two tablets deliver the medicine to the body in the same way. This is called a 'bioequivalence' study. They are testing it in healthy adult volunteers who have just eaten a meal. This kind of study helps ensure that if a new version of a drug becomes available, it will work just as well as the original to help people with conditions like certain types of leukaemia.
At a glance
What is this study about?
This study is a type of research called a 'bioequivalence' study. Imagine you have two identical keys, but they're made by different companies. This study is like checking if both keys open the same lock in exactly the same way. In this case, the 'keys' are two different versions of a medicine called imatinib. One is the well-known original version, Glivec, and the other is a new version made by Sun Pharmaceutical Industries.
The main aim is to make sure that the new imatinib tablet delivers the same amount of medicine into the body, and at the same speed, as the original Glivec tablet. This is really important because if a new version of a medicine is going to be used, doctors and patients need to be confident that it will work just as effectively as the original. This particular medicine, imatinib, is used to treat serious conditions like specific types of leukaemia.
By ensuring the new tablet is just as effective, it could potentially offer more options for patients and the healthcare system in the future. This study is an important early step in deciding if a new version of a medication can be widely used while still providing the same trusted results as the original.
Key takeaways
- Compares a new imatinib tablet to the original Glivec.
- Aims to ensure the new tablet works just as effectively.
- Participants are healthy adults, aged 18 and over.
- Involves taking medication and giving blood samples.
- Helps advance medicine for leukaemia patients.
- Participation is voluntary, and you can withdraw anytime.
Who may be eligible?
To take part in this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
Since this is an early-stage study to compare how medicines work in the body, it is only for healthy volunteers. This means you should not have any serious or ongoing health problems.
More detailed checks will be done by the study doctors to make sure it's safe for you to participate and that your results will be clear and useful for the study.
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 in good health?
- Are you able to follow study instructions carefully?
- Are you comfortable with giving regular blood samples?
- Are you available for potentially multiple visits or overnight stays?
What does participation involve?
If you decide to take part, you'll be given both types of imatinib tablets at different times, but you won't know which one you're receiving. This is a 'crossover' study, meaning you'll get both treatments, but separated by a break. You'll take the medicine after eating a meal. Throughout the study, medical staff will take blood samples regularly to measure how your body is handling the medicine. They will also check your general health. The exact number of visits and the total time you'll be involved will be explained by the study team, but typically these kinds of studies involve a few overnight stays and follow-up visits over several weeks.
Potential risks and benefits
Locations (1)
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Common questions
What is imatinib?
Imatinib is a medicine used to treat certain cancers, especially specific types of leukaemia, by targeting faulty signals within cancer cells.
What does 'bioequivalence' mean?
Bioequivalence means that two different versions of a medication deliver the same amount of active drug to your body, at the same speed, as if they were identical.
Why is this study only for healthy people?
Because this study wants to see how the medicine works in the body without other illnesses affecting the results. This helps them get a clear comparison between the two tablets.
Will I know which tablet I am taking?
No, in this type of study, you won't know whether you're taking the new tablet or the original one at any given time. This helps keep the results unbiased.
Will I be paid to take part?
Many clinical trials offer some payment for your time and travel, especially those involving healthy volunteers, but you would need to ask the study team for details.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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