AuthorisedHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence of Lisdexamfetamine dimesylate 10 mg Capsules in Healthy Participants Under Fasting Conditions.

This research study is looking at a new version of a medicine called lisdexamfetamine dimesylate, specifically the 10 mg capsules. It's called a 'bioequivalence study' and its main goal is to find out if this new version of the medicine works in the body in the exact same way as the original medicine. This is done by giving the medicine to healthy adult volunteers and then measuring how much of the medicine gets into their bloodstream and how quickly. Participants will take the medicine without eating beforehand. Studies like this are very important because they help ensure that when a new, often cheaper, version of a medicine is made, it will be just as safe and effective as the original for patients.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Pharmaplot P.C.

Enrolment target

Start

20 Dec 2024

No medical condition.

What is this study about?

This study is focused on a medicine called lisdexamfetamine dimesylate, specifically the 10-milligram capsules. When a company makes a new version of an existing medicine, especially if it's a 'generic' version, they need to show that it works just as well as the original. This type of study, called a 'bioequivalence' study, is designed to do exactly that.

In simple terms, 'bioequivalence' means that two versions of the same medicine deliver the same amount of the active ingredient into the bloodstream at the same speed. This is crucial because it ensures that patients will get the same treatment effect, whether they take the original medicine or the new version.

The main purpose of this study is to compare how the body handles the new lisdexamfetamine dimesylate 10 mg capsule when it's taken without food, compared to the original medicine. By understanding this, doctors and pharmacists can be confident that if a patient switches from one version of the medicine to another, their treatment won't be affected.

Key takeaways

This study compares a new version of lisdexamfetamine dimesylate 10 mg capsules to the original.
It's a 'bioequivalence' study, meaning it checks if both versions work the same way in the body.
Only healthy adults, aged 18 and over, can take part.
Participants will take the medicine without food (fasting conditions).
Blood samples will be taken to see how the body absorbs the medicine.
Your participation helps ensure new medicines are just as safe and effective.

Who may be eligible?

This study is looking for healthy adults to take part. This means we are not looking for people with any specific medical conditions or illnesses for this particular research.

To be eligible, you simply need to be 18 years old or older. There is no upper age limit for participating, as long as you are considered generally healthy. Both men and women are welcome to join.

Because this study focuses on how the medicine is absorbed when you haven't eaten, you'll need to be able to follow specific instructions about fasting beforehand.

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, without any long-term medical conditions?
Are you able to follow specific instructions about not eating or drinking (fasting) before taking medicine?
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 in this study, you will be asked to spend some time at a research clinic. You'll be given the study medicine (lisdexamfetamine dimesylate 10 mg capsules) to take. There will be specific instructions about not eating or drinking (fasting) before you take the medicine.

After you take the medicine, the research team will take blood samples at set times. These blood samples will help them measure how much of the medicine gets into your body and how it's processed. You'll likely have a few visits or perhaps a short stay at the clinic for these measurements. The total length of your involvement will be clearly explained to you before you agree to participate.

Potential risks and benefits

Taking part in any study has potential upsides and downsides. A potential benefit of taking part is that you would be contributing to medical science, which helps to ensure that new medicines are safe and effective for everyone. You might also receive payment for your time and travel. Potential risks could include minor discomfort from blood tests (like bruising or soreness) or possible side effects from the study medicine, although this specific medicine is already approved and well-known. You will be told about all known side effects before you decide. Remember, 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.

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Unverified
Portugal

Common questions

What does 'bioequivalence' mean?

It means we're checking if a new version of a medicine works in the body in the same way as the original, delivering the same amount of medicine at the same speed.

Why is this study only for healthy people?

Studies like this use healthy volunteers to focus purely on how the body handles the medicine, without other health conditions affecting the results.

Will I have to fast?

Yes, you will need to follow specific instructions about not eating or drinking before taking the medicine to ensure accurate testing.

What kind of medicine is lisdexamfetamine dimesylate?

It is a prescription medicine, and this study is testing a 10 mg capsule version, likely for conditions like ADHD, though this study doesn't involve treating any condition.

Will I be paid for participating?

It's common for studies involving healthy volunteers to offer payment for time, travel, and inconvenience. You would be told about this before joining.