Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence of Lisdexamfetamine dimesylate 20 mg Capsules in Healthy Participants Under Fasting Conditions.

Scientists are doing a study to compare a new type of medication with an existing one. The medication, called Lisdexamfetamine dimesylate, is used for certain health conditions, but this study isn't looking at those conditions directly. Instead, it's about checking if the new version of the medication acts the same way in the body as the original. This is important to make sure it's just as effective and safe. Healthy adult volunteers will take the medication on an empty stomach. Researchers will then observe how their bodies absorb, use, and remove the medicine. This kind of study helps ensure that new medications are reliable before they become widely available.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Pharmaplot P.C.

Enrolment target

Start

02 Oct 2024

No medical condition.

What is this study about?

Imagine you have a key, and a new company makes a copy of that key. This study is like making sure the copy opens the lock just as well as the original key. Here, the 'key' is a medication called Lisdexamfetamine dimesylate. This medication is already approved and used for certain health problems, but this study isn't about treating any illnesses. It's purely about checking if a new version, or 'copy,' of this medication works exactly the same way in healthy people.

When a new version of a medication is made, it's really important to prove that it acts in the body in the same way as the original. This is called 'bioequivalence.' It means that the amount of medicine that gets into your bloodstream and how quickly it gets there should be very similar to the original drug. This study is the first step in testing this new version in people.

By carefully comparing how the new medication behaves in healthy adults, researchers can gather the information needed to show it's just as good as the original. This process helps ensure that new medications are trustworthy and will have the expected effects when they are eventually used by patients who need them.

Key takeaways

This study is testing a new version of an existing medication.
It's checking if the new medication works the same way in the body as the original.
Only healthy adults are eligible to take part.
You'll need to go without food before taking the medication.
Your blood will be regularly checked to see how your body uses the medicine.
Your participation helps ensure new medications are safe and effective.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 or older. "Healthy" means you don't have any major ongoing medical conditions that would affect how your body handles the medicine.

Both men and women are welcome to take part. Since the study is comparing how the medication works in healthy people, you won't be eligible if you have certain health problems that could change the way your body reacts to the drug.

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?
Do you consider yourself generally healthy?
Are you able to follow study instructions carefully?
Are you comfortable with having blood samples taken?
Can you commit to attending multiple clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll visit a clinic several times. During these visits, you'll be given the study medication (Lisdexamfetamine dimesylate) to take on an empty stomach. Healthcare professionals will take blood samples at specific times to see how the medication is moving through your body. There might also be other checks, like measuring your heart rate or blood pressure.

You'll likely need to stay at the clinic for some hours after taking the medication, or possibly overnight, depending on the study schedule, so that all the necessary measurements can be taken. The study period will involve a few rounds of taking the medication and having tests, with short breaks in between. The total time you're involved from your first visit to your last follow-up will be explained to you.

Potential risks and benefits

Potential benefits include contributing to medical science and helping to make new medications available and safe for future patients. You will also receive careful medical monitoring during the study period. Potential risks are generally mild, such as discomfort from blood draws, or temporary side effects from the medication, which will be fully explained to you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Portugal

Common questions

What is Lisdexamfetamine dimesylate normally used for?

It's a medication prescribed for conditions like Attention-Deficit/Hyperactivity Disorder (ADHD) and certain eating disorders, but this study is not looking at these conditions.

Will I get paid for taking part?

Many clinical studies offer some payment for your time and inconvenience; this will be fully explained before you agree to join.

Is this a new medication?

It's a new version of an existing medication. The study is checking if this new version works the same way as the original.

Do I need to stop taking my regular medicines?

You will be given clear instructions on what medications, if any, you need to stop before or during the study. This will be discussed with you in detail.

What does 'fasting conditions' mean?

It means you won't be allowed to eat or drink anything (except water) for a certain number of hours before taking the study medication. Full instructions will be provided.