An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioequivalence study comparing Enzalutamide film coated tablets 160 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' designed to compare a new film-coated tablet of Enzalutamide (a medicine used for prostate cancer) with the existing version. The main goal is to see if the new tablet is absorbed into the body in the same way as the original. This is important to ensure that patients get the same amount of medicine, and therefore the same benefits, regardless of which version they take. The study involves healthy adult men who will take both drugs at different times to allow for a direct comparison under fasting conditions. This is a common and important step in developing new medicines.
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 company wants to make a new version of an existing medicine, like a generic version, they need to show that it works just as well as the original. This is called a 'bioequivalence' study. Essentially, it means they are checking if the new drug is absorbed into the body at the same speed and to the same extent as the original one, when taken in the same way. If they are 'bioequivalent,' it means they should have the same medical effect.
Think of it like this: if you have a classic recipe and someone makes a slightly different version, you'd want to make sure the new version tastes just as good and has the same effect as the original. In medicine, this ensures that patients who switch to the new version will get the same benefits and experience the same side effects as with the original.
This particular study involves healthy volunteers rather than patients with prostate cancer. This is a common approach in these types of studies because it avoids potential complications from existing illnesses or other medications. By using healthy people, researchers can focus purely on how the drug is absorbed and processed by the body, which helps them determine if the new version is a good match for the original.
Key takeaways
- This study compares a new version of Enzalutamide with an existing one.
- It aims to ensure both versions of the drug work the same way in the body.
- Only healthy adult men are eligible to take part.
- Participants will receive single doses of both drugs, taken under fasting conditions.
- The study involves multiple clinic visits for monitoring and blood tests.
- Your participation helps to make sure patients get safe and effective medicines.
Who may be eligible?
This study is looking for healthy adult men to take part. To be eligible, you need to be at least 18 years old. There is no upper age limit, so older men can also participate if they are otherwise healthy.
Because this is a study designed to compare how two versions of a drug are absorbed, it's really important that participants are generally well. This helps researchers get clear results without other health conditions or medicines complicating things.
You would not be able to join if you are female, or if you have any significant health problems that could affect how your body handles the medication, or if you are taking other regular medications that might interfere with the study drugs. The research team will run checks to make sure you're a good fit.
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 male?
- Are you 18 years old or older?
- Are you generally healthy?
- Are you prepared to fast before taking medication?
- Are you willing to attend multiple clinic visits?
- Are you comfortable with having regular blood samples taken?
What does participation involve?
If you decide to take part, you would receive a single dose of one version of the drug, and then, after a break, a single dose of the other version. This is called a 'crossover' study. Both doses would be taken while you are fasting, meaning you wouldn't have eaten anything for a certain period before taking the medicine. Throughout the study, you would attend several appointments at the clinic. During these visits, the research team would monitor your health and take blood samples at specific times after you take each dose. This allows them to measure how much of the drug is in your body and how it changes over time. The total duration of your involvement would cover these two separate drug-taking periods and follow-up activities, likely spanning a few weeks.
Potential risks and benefits
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Common questions
What is Enzalutamide used for?
Enzalutamide is a medicine used to treat prostate cancer.
Why are they testing healthy men if it's for cancer?
They use healthy men to see exactly how the drug is absorbed into the body, without other health problems affecting the results.
What does 'fasting condition' mean?
It means you won't be allowed to eat food for a certain period before taking the medicine, usually overnight.
What is a 'crossover study'?
It means you will take one version of the drug, and then later take the other version, so researchers can directly compare them in the same person.
Will I know which drug I'm receiving?
Yes, in this type of study ('open label'), you, and the researchers, would generally know which drug you are taking at each stage.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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