Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence of Lisdexamfetamine dimesylate 10 mg/mL Oral Solution in Healthy Participants Under Fasting Conditions.

This study is looking at a new liquid form of a medicine called lisdexamfetamine. This medicine is often used for conditions like ADHD. The main goal is to check if this new liquid version is absorbed by the body in the same way as the established tablet form. This type of study, called 'bioequivalence,' helps make sure new forms of medicines work reliably. They are looking for healthy adults, aged 18 and older, to take part. Participants will be asked to fast before taking the medicine and will have several blood tests. This helps scientists understand how the body handles the medicine when it's taken as a liquid.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Pharmaplot P.C.

Enrolment target

Start

22 Oct 2024

No medical condition.

What is this study about?

This study is designed to understand how a new liquid version of a medicine called lisdexamfetamine works in the body. You might know lisdexamfetamine as a medicine prescribed for conditions like attention deficit hyperactivity disorder (ADHD). Currently, this medicine is typically taken as a tablet or capsule.

The researchers want to see if this new liquid form is absorbed into the bloodstream and acts in the body in the same way as the existing tablet. This comparison is very important because it helps ensure that if the liquid medicine becomes available, it will be as effective and safe as the tablet form people are already using. It's a key step in developing new ways for people to take their medication, especially if they have trouble swallowing pills.

This kind of study is called a 'bioequivalence' study. It's a common and necessary part of developing new medicines or new ways to take existing ones. By taking part, you'd be helping scientists understand more about how our bodies process medication, which can ultimately lead to more choices for patients in the future.

Key takeaways

This study tests a new liquid form of an ADHD medicine.
It aims to see if the liquid works like the current tablets.
Only healthy adult volunteers are needed.
Participation involves fasting and blood tests.
Your contribution helps develop new medicine options.

Who may be eligible?

The study is looking for healthy adults. This means you should generally be well and not have any serious ongoing medical conditions. The researchers want to make sure that any effects seen are due to the medicine itself and not other health problems.

You need to be at least 18 years old to take part, and there isn't an upper age limit mentioned. Both men and women are welcome to participate in this study. They will check your health carefully to make sure it's safe for you to take part.

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 generally healthy with no serious medical conditions?
Are you 18 years old or older?
Are you able to follow study instructions, including fasting?
Are you comfortable with having blood samples taken?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to come to a study center for a few visits. Before each dose of the medicine, you'll need to fast, which means not eating for a certain period. You'll then take the liquid medicine. To see how your body absorbs the medicine, blood samples will be taken regularly after you've taken the dose. There will also be general health checks, like measuring your blood pressure and heart rate.

The total amount of time you'd spend in the study and the exact number of visits haven't been detailed here, but these studies usually involve a screening visit, one or more dosing visits where you stay at the clinic for a day, and possibly a follow-up call or quick visit. You won't be taking this medicine long-term as part of the study; it's about seeing its short-term effects.

Potential risks and benefits

The main benefit of taking part in this study is contributing to medical science, which can help develop new options for patients in the future. As with any medicine, there's always a chance of side effects, even in healthy people. These might include common effects like headaches or feeling a bit jittery. The procedures, such as blood tests, also carry small risks, like bruising. All potential risks will be fully explained before you agree to take part. You have the right 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.

—
Unverified
Portugal

Common questions

What is lisdexamfetamine?

It's a medicine often prescribed for conditions like ADHD. This study is looking at a new liquid version of it.

Why is this study being done?

Researchers want to see if a new liquid form of the medicine works the same way as the current tablet form in the body.

Do I need to be ill to join?

No, this study is specifically looking for healthy adults, meaning people who are generally well.

What will I have to do if I join?

You'll likely have a few visits, fast before taking the medicine, and have blood samples taken to see how your body absorbs it.

Will I get paid for taking part?

The information provided doesn't say, but it's common for healthy volunteer studies to offer some payment for your time and travel.