An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioequivalence study comparing Bosutinib Tablets 100 mg, Manufactured by Sun Pharmaceutical Industries Limited, India with Bosulif (bosutinib) 100 mg, Manufactured and Packed by: Pfizer Manufacturing Deutschland GmbH Betriebsstätte Freiburg Mooswaldallee, Freiburg, Germany, Imported by: Pfizer Brasil Ltda. Rodovia Presidente Castelo Branco, nº32501, km 32.5 CEP 06696-000 – Itapevi – SP, in healthy adult, human subjects under fed condition.
This early-stage study, called a bioequivalence study, is looking at a new version of a drug called bosutinib. Bosutinib is used to treat a type of cancer called myeloid leukaemia. The study wants to find out if this new version works in the body in the same way as the original drug. To do this, healthy adult volunteers will take both versions of the drug at different times, after they have eaten. Researchers will then measure how the drug levels change in their bodies. If the new version is 'bioequivalent', it means it’s absorbed and used by the body just like the original, which suggests it will have the same effects and safety profile. This kind of research is important before a new drug can be made widely available.
At a glance
What is this study about?
This clinical trial is designed to compare two different versions of a medication called bosutinib. Bosutinib is a drug prescribed to people with a type of blood cancer called myeloid leukaemia. The main goal of this study is to see if a newly made bosutinib tablet works in the body in the exact same way as the already approved bosutinib tablet.
To figure this out, healthy adult volunteers will take both versions of the drug. Researchers will then carefully measure how much of the drug gets into the bloodstream and how quickly. This is done after the volunteers have eaten, as food can sometimes affect how medicines are absorbed. If the new drug acts like the original one, it's called "bioequivalent." This means it's likely to be just as safe and effective for patients.
Studies like this are a really important first step when a pharmaceutical company wants to make a new version of a drug. It helps ensure that any new medicine made available to patients will work as expected, providing doctors and patients with confidence in its quality and effectiveness.
Key takeaways
- This study compares a new version of the cancer drug bosutinib with an existing one.
- It aims to see if both versions work the same way in the body.
- Healthy adults (18+) will take single doses of each drug after eating.
- Blood samples will be taken to measure drug levels.
- This research helps ensure new drugs are just as safe and effective.
- Participation will involve clinic visits and blood tests.
Who may be eligible?
This study is looking for healthy adult volunteers. Most importantly, you need to be 18 years old or older to take part. There isn't an upper age limit mentioned, so older adults could also be eligible, as long as they are generally healthy.
Both men and women are welcome to participate in this research. The study needs healthy individuals because it wants to see how the drug behaves in a body that isn't affected by other illnesses or medications, making the comparison between the two drug versions clearer and more accurate.
- Are you 18 years old or older?
- Are you generally healthy?
- Are you comfortable with taking a medication and having multiple blood samples taken?
- Are you available for a few clinic visits over a short period?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
This is a "crossover" study, meaning you would receive both the new and standard versions of the drug at different times. You would likely visit the study clinic for at least two separate sessions. During each session, you would take a single dose of one of the medications after eating a meal. Throughout the day, healthcare staff would take blood samples at specific intervals to measure drug levels in your body. There might be some follow-up checks after each dose, and the total duration from your first dose to your final check-up would be determined by the study protocol, but typically these types of studies run for a few weeks.
Potential risks and benefits
Locations (1)
- —Romania
Common questions
What is bosutinib used for?
Bosutinib is a medication used to treat a type of blood cancer called myeloid leukaemia.
Why is this study only for healthy people?
The study uses healthy volunteers to clearly see how the drug behaves in the body without other health conditions or medications complicating the results.
What does 'bioequivalence' mean?
It means the new drug works in the body in the same way as the original drug, reaching similar levels in the blood at similar times.
Will I get both versions of the drug?
Yes, in this type of study, you will receive both the new and existing versions of the drug at different times, as part of a crossover design.
Do I have to stay overnight for the study?
The study design suggests multiple visits for doses and blood collection, but whether overnight stays are required would depend on the detailed schedule provided by the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.