An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioequivalence study comparing Enzalutamide film coated tablets 80 mg, Manufactured for Sun Pharmaceutical Industries Limited, India with XTANDI (Enzalutamide) 80 mg film coated tablets, Made by: Patheon Inc., 2100 Syntex Court, Mississauga, Ontario – Canada, Imported and registered by: Astellas Farma Brasil Importação e Distribuição de Medicamentos Ltda., São Paulo-SP, Brazil, in healthy adult, male subjects under fasting condition.
This research is a 'bioequivalence study' looking at a medicine named enzalutamide, which is used to treat prostate cancer. Scientists want to check if a new, more affordable version of the 80 mg enzalutamide tablet works in the human body in the exact same way as the established brand-name version. To do this, healthy adult men will be given a single dose of each medicine at different times, and doctors will compare how the medicine is absorbed and processed. This is important to ensure that if a generic version is approved, it will be just as safe and effective as the original drug for patients with prostate cancer.
At a glance
What is this study about?
This study is about a medicine called enzalutamide, which is used to treat prostate cancer. When a new medicine is first developed, it's often protected by a patent, meaning only one company can make it. After a while, other companies can start making their own versions, often called 'generic' medicines. These generics are usually much cheaper, which makes them more accessible to people who need them.
However, before a generic medicine can be used, we need to be sure it works just as well as the original. That's where this study comes in. It's a 'bioequivalence study,' which means scientists are comparing a new generic version of enzalutamide with the original brand-name version. They want to check if both medicines deliver the same amount of the drug to the body at the same speed.
If the generic medicine is found to be 'bioequivalent' – meaning it acts the same way in the body – then doctors can be confident that patients will get the same treatment benefits as with the original drug, but potentially at a lower cost. This study is an important step in making effective prostate cancer treatment more widely available.
Key takeaways
- Compares a new generic prostate cancer medicine with the original.
- Aims to ensure the generic medicine works just as well.
- Involves healthy adult men, not prostate cancer patients.
- Requires taking single doses of two different medicines.
- Will involve blood tests and health checks to monitor the medicine.
- Helps make important cancer treatments more affordable and available.
Who may be eligible?
To take part in this study, you need to be an adult man. The study is particularly looking for healthy men, not those who are currently being treated for prostate cancer, as the goal is to see how the medicine works in a typical, healthy body without other health issues impacting the results.
You should be at least 18 years old. There isn't an upper age limit mentioned, but you would need to be fit and healthy enough to participate.
The researchers will perform some health checks to make sure it's safe for you to take part and that your health status won't affect the study results. They will explain all the specific health requirements in detail if you are interested.
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 an adult man?
- Are you generally healthy?
- Are you at least 18 years old?
- Are you able to follow study instructions, including fasting?
- Are you willing to have regular blood samples taken?
What does participation involve?
If you decide to take part in this study, you would be asked to visit the study clinic multiple times. You would receive a single dose of the original enzalutamide tablet on one occasion and a single dose of the new generic enzalutamide tablet on another occasion. These would be given under 'fasting conditions,' meaning you wouldn't eat anything for a certain period before taking the medicine.
After each dose, doctors and nurses would take blood samples at specific times to measure how much of the medicine is in your body and how it's being processed. You would also have regular health checks, including physical examinations, to make sure you are well throughout the study. The total duration of your involvement, including all visits and follow-up, would be fully explained to you before you agree to join.
Potential risks and benefits
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Common questions
What is 'bioequivalence'?
Bioequivalence means that two medicines, even if made by different companies, act the same way in the body and are expected to have the same effects.
Why is this study using healthy men, not prostate cancer patients?
Using healthy men helps researchers see how the medicine works on its own, without other health conditions or treatments interfering with the results.
Will I receive treatment for prostate cancer?
No, this study is not a cancer treatment. It's about comparing how a medicine is absorbed in healthy individuals.
Will I have to stay overnight for the study?
While the details aren't specified, studies like this often involve overnight stays or long clinic visits to monitor the drug's levels in your body.
Is enzalutamide safe to take if I don't have prostate cancer?
All potential risks and side effects of taking enzalutamide will be thoroughly explained by the study team, and your health will be closely monitored.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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