An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of Single Entity Amphetamine Product) 30 mg, manufactured by Frontida Biopharm. Inc., Philadelphia, USA with Attent 30 mg (Mixed Amphetamine Salts tablets) manufactured by Teva Israel Ltd., in healthy adult, human subjects under fasting condition.
This research is looking at a new 30mg tablet for ADHD, made by Frontida Biopharm, and comparing it to an existing 30mg ADHD medication called Attent, made by Teva Israel. The main goal is to see if these two medicines are "bioequivalent," which means checking if they deliver the same amount of medication to the body in the same way. This study involves healthy adult volunteers who will take a single dose of each medication on different occasions. It's a "crossover" study, so each participant will try both medicines at different times. This crucial first step helps ensure that any new version of a medicine will work just as safely and effectively as the original for people with ADHD.
At a glance
What is this study about?
You might have heard about different versions of the same medicine. This study is all about making sure a new version of an ADHD medication works exactly like one that's already out there. Think of it like comparing two different brands of a common painkiller – they both contain the same active ingredients, but a study like this helps check that your body processes them in the same way.
Specifically, this research is comparing a new 30mg tablet for ADHD from Frontida Biopharm with an existing 30mg ADHD medicine called Attent from Teva Israel. They both contain a mix of amphetamine salts, which is a common type of medication used to help manage ADHD symptoms. The study wants to be absolutely sure that the new tablet delivers the medication to your body at the same speed and in the same amount as the original one.
This kind of study is really important because it helps regulatory bodies like the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK ensure that new, possibly more affordable, versions of medicines are just as safe and effective as the treatments already available. It ensures that when you get a prescription, you can be confident that the medicine will work as expected, regardless of which company made it.
Key takeaways
- This study compares a new ADHD medicine with an existing one.
- It aims to ensure both medicines work the same way in the body.
- Only healthy adults, aged 18 and over, can take part.
- Participants will receive a single dose of each medicine at different times.
- Blood samples will be taken to see how the body absorbs the medication.
Who may be eligible?
This study is looking for healthy adults to take part. To be considered, you need to be at least 18 years old.
Because this is a very early stage study, it focuses on healthy people rather than those who actually have ADHD. This helps researchers understand how the medicine works in the body without other health conditions making things more complicated. All genders are welcome to participate.
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 in good health?
- Are you able to attend clinic visits?
- Are you able to follow study instructions, like fasting?
What does participation involve?
If you join this study, you would be asked to visit the study clinic two separate times. Each visit would involve staying at the clinic for a short period. On each visit, you would receive a single dose of one of the study medications (either the new one or the existing one). You would need to be fasting, meaning you won't have eaten for a certain number of hours before taking the medicine. Your blood would be drawn at specific times after taking the medication to see how your body absorbs and processes it. There will be a "washout" period between the two visits, meaning a break where you don't take any study medication, to make sure the first dose is completely out of your system before you take the second. The total time you'd be involved in the study, including the washout period, would be explained to you in detail.
Potential risks and benefits
Locations (1)
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Common questions
What is bioequivalence?
It means two medicines give your body the same amount of medication at the same speed, ensuring they work equally well.
Why include healthy adults?
Using healthy people helps understand how the medicine works without other health conditions affecting the results.
Will I get paid for taking part?
Compensation for your time and travel is often provided for these types of studies; you would be informed about this.
What's a 'crossover' study?
It means you'd get both medicines at different times, so researchers can compare them within the same person.
What happens after the study?
Once the study is finished, all medication will be out of your system, and you'll return to your usual activities.
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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