A double blinded, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study comparing Lisdexamfetamine Dimesylate capsules 10 mg, manufactured by Ohm Laboratories Inc. (A Sun Pharma Company), 14 Terminal Road, New Brunswick, 08901, NJ, USA with Vyvanse (Lisdexamfetamine Dimesylate) 10 mg capsules; Product of Takeda Canada Inc., Toronto Ontario ON M5H 4E3, Canada, in healthy adult, human subjects under fasting condition.
This research study is looking at a new version of a medicine for ADHD called Lisdexamfetamine Dimesylate. It's being compared to the existing brand, Vyvanse, which also contains Lisdexamfetamine Dimesylate. The main goal is to see if these two medicines are absorbed by the body in the same way and at the same speed. This type of study, called a bioequivalence study, is important because it helps ensure that a new, often more affordable, version of a medicine will work just as well as the original. Healthy adults will be given a single dose of each medicine on separate occasions after not eating. The study aims to make sure future patients can trust that different brands of the same medication will be equally effective.
At a glance
What is this study about?
This research study is about a medication called Lisdexamfetamine Dimesylate, which is used to treat Attention Deficit Hyperactivity Disorder (ADHD). There's an existing brand of this medicine called Vyvanse. Now, a different company has made their own version of the same medicine. Before this new version can be widely used, doctors and scientists need to make sure it works in exactly the same way as the original Vyvanse.
This type of study is called a 'bioequivalence study'. In simple terms, 'bio' means related to the body, and 'equivalence' means being equal. So, the study is checking if the new medicine behaves in the body in an equivalent way to the original medicine. This involves seeing if the new medicine is absorbed into the bloodstream at the same speed and to the same extent as the original.
Finding that a new medicine is bioequivalent to an existing one is a very important step. It means that patients can potentially have more choices for their medication, and often, these new versions can be more affordable. This study helps ensure that these new medications are just as safe and effective as the ones we already know and trust.
Key takeaways
- This study compares a new version of an ADHD drug to the original.
- The goal is to prove both versions work the same way in the body.
- Healthy adults (18+) can participate, both men and women.
- It involves taking a single dose of each drug on separate occasions after fasting.
- This research helps make sure new medicines are safe and effective.
- Participation involves contributing to science and medical checks.
Who may be eligible?
This study is designed for healthy adults. You need to be at least 18 years old to take part, and there's no upper age limit mentioned.
Both men and women are welcome to participate. The study is specifically looking for people who are generally healthy, not those currently treating ADHD or other long-term conditions with medication.
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 healthy?
- Are you able to follow study instructions, including fasting?
- Are you willing to participate in several clinic visits?
- Do you understand this is for research, not for treating your own ADHD?
What does participation involve?
If you decide to take part in this study, you would receive a single dose of medication on two separate occasions. On each occasion, you would have fasted (not eaten) beforehand. You would be given either the new Lisdexamfetamine Dimesylate capsule or the Vyvanse capsule. You would then be monitored, likely having blood samples taken over several hours, to see how your body absorbs the medicine. After a washout period (a break to allow the first medicine to leave your system), you would return to receive the other medicine you hadn't taken yet, and the process would be repeated. The exact number of visits and the total time involved isn't detailed here but typically these studies involve several clinic visits over a few weeks.
Potential risks and benefits
Locations (1)
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Common questions
What is ADHD?
ADHD stands for Attention Deficit Hyperactivity Disorder. It's a condition that can affect a person's attention, activity levels, and impulse control.
What does 'bioequivalence' mean?
It means researchers are checking if a new version of a medicine works the same way in the body as an existing, approved version.
Why is this study important if it's already an approved medicine?
This study is comparing a new version (made by a different company) to the original. This helps ensure that the new version is just as effective and safe for patients.
Do I need to have ADHD to join?
No, this study is looking for healthy adults. They want to see how the medicine acts in generally healthy bodies, not how it treats ADHD itself.
What is 'fasting condition'?
It means you wouldn't eat anything for a certain period, usually overnight, before taking the medication in the study.
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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