An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Lisdexamfetamine Dimesylate capsules 70 mg, manufactured by Sun Pharmaceutical Industries Limited, India with VENVANSE (lisdexamfetamine dimesylate) 70 mg Hard Gelatin Capsule, imported and registered by: Takeda Pharma Ltd. Rodovia SP 340 S/N, km 133.5, Ed. Adm. Jaguariúna-SP CNPJ 60.397.775/0001-74 and manufactured by: Patheon Pharmaceuticals Inc. Cincinnati, United States of America or Takeda Pharma Ltd. Rodovia SP 340 S/N, km 133.5, Ed. QC - Jaguariúna – SP, Brazilian industry in healthy adult, human subjects under fasting condition.
This research study is looking at a new version of a medicine called lisdexamfetamine dimesylate, which is used to treat conditions like ADHD and Binge Eating Disorder. The study wants to see if this new version, made by Sun Pharma, works in the exact same way as the established medicine, Elvanse (which also contains lisdexamfetamine dimesylate). To do this, healthy adult volunteers will take both medicines at different times, and scientists will measure how the medicines travel through their bodies. This is important to ensure that if the new medicine becomes available, it will be just as safe and effective as the one currently prescribed.
At a glance
What is this study about?
This study is all about checking a new version of a medicine called lisdexamfetamine dimesylate. You might know this medicine by its brand name, Elvanse, which is used to help people with conditions like ADHD (Attention Deficit Hyperactivity Disorder) and BED (Binge Eating Disorder).
The main goal of this study is to make sure that the new version of the medicine, which is being made by a company called Sun Pharma, works exactly the same way as the Elvanse medicine you might already be familiar with. Think of it like comparing two different brands of a common painkiller – they both contain the same active ingredient, but this study checks if your body uses them in the same way. This is very important because it helps ensure that if the new version is approved for use, it will be just as effective and safe as the original.
To do this, healthy adult volunteers will participate. They will take both medicines, but not at the same time. Researchers will then take blood samples to measure how quickly and how much of the medicine gets into their system and how long it stays there. This helps them understand if the new medicine is 'bioequivalent' – a fancy word meaning it behaves identically in the body to the existing one.
Key takeaways
- This study compares a new version of Elvanse with the original.
- It aims to prove they work the same way in the body.
- Healthy adults (18+) are needed to participate.
- You'll take both medicines at different times, with blood tests.
- It helps ensure new medicines are safe and effective.
- Your participation is voluntary, and you can withdraw anytime.
Who may be eligible?
To take part in this study, you need to be a healthy adult, meaning you are 18 years old or older. The study is open to both men and women.
Being 'healthy' means you usually don't have any major ongoing health problems. The researchers want to make sure that any effects they see are from the medication itself and not from other health conditions you might have.
While the medication is used for ADHD and Binge Eating Disorder, this particular study is for healthy volunteers only. This helps compare the medicines without the complications of existing conditions.
- Are you 18 years old or older?
- Do you consider yourself generally healthy?
- Are you comfortable with blood tests?
- Can you follow specific instructions like fasting before medicine?
- Are you able to attend several 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'll be asked to visit a special clinic a few times. During these visits, you'll take one of the study medicines (either the new version or Elvanse) on different occasions, with a break in between to allow the first dose to leave your system. Before taking the medicine, you'll be asked not to eat for a certain period, which is called 'fasting'.
After you take the medicine, the study team will take several small blood samples at different times over a number of hours. This is how they measure how the medicine works in your body. You'll be closely monitored by medical staff during your visits.
This type of study usually involves staying at the clinic for a short period during each 'period' of the study and then returning for follow-up checks. The total time for your participation will depend on how many times you need to take the medicines and have your blood tested.
Potential risks and benefits
Locations (1)
- —Romania
Common questions
What is 'bioequivalence'?
It means checking if two different versions of the same medicine work in exactly the same way in your body.
Why use healthy people for a medicine for ADHD?
Researchers use healthy people for this initial check to understand how the medicine behaves without other health conditions making the results unclear.
Will I know which medicine I'm getting?
Yes, this is an 'open label' study, which means you and the researchers will know which medicine you are taking at each stage.
Do I have to fast before taking the medicine?
Yes, you will need to fast, meaning not eat, for a certain time before taking the study medicine. Instructions will be provided.
Will I get paid for taking part?
Often, studies like this offer payment to volunteers for their time and travel. You should ask the study team about this.
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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