Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Comparative Bioavailability of Lisdexamfetamine Dimesylate 70 mg in Healthy Subjects Under Fasting Conditions

This clinical trial is designed to see how a specific dose (70mg) of a medicine, lisdexamfetamine dimesylate, is taken in by the body when healthy people take it on an empty stomach. This is a "bioequivalence" study, which means researchers want to compare how two different versions or ways of taking the same medicine behave in the body. It's an early-stage study, meaning it helps scientists understand the basic way a medicine works before it's tested for specific health conditions. Participants will be healthy adults, and it's not looking to treat any illness.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Pharmaplot P.C.

Enrolment target

Start

13 Mar 2024

No medical condition.

What is this study about?

This study is all about understanding a medicine called lisdexamfetamine dimesylate. Specifically, the researchers want to see how a 70mg dose of this medicine is absorbed and used by the body in healthy adult volunteers when they haven't eaten anything beforehand. Think of it like a test to see how quickly and how much of the medicine gets into your bloodstream. This kind of study is called a 'bioequivalence' study, which helps compare if two versions of a medicine, or the medicine given in two different ways, act the same in the body.

This is an early-stage study, sometimes called Phase I. These studies are really important because they give scientists a clear picture of how a medicine works on a basic level in the human body, focusing on safety and how the body handles the drug rather than treating a specific illness. It helps them decide if and how to move forward with further testing for particular health conditions later on. So, while this particular study isn't about treating an illness, it's a crucial step in understanding the medicine.

The information gathered from studies like this helps pharmaceutical companies and doctors understand how a medicine should be given to patients in the future. It ensures that when this medicine is eventually used for people who need it, it will be absorbed effectively and safely. It's foundational work that makes sure medicines are developed properly and reliably.

Key takeaways

This study helps understand how a medicine is absorbed by the body.
It's for healthy adults, not for treating any illness.
Participants will take a 70mg dose of lisdexamfetamine dimesylate.
The study looks at absorption when the medicine is taken on an empty stomach.
This is an early and important step in developing new medicines.

Who may be eligible?

To be able to take part in this study, you need to be a healthy adult aged 18 years or older. There is no upper age limit mentioned, so anyone over 18 can be considered.

The study is open to both men and women. Because this study is looking at how a medicine is absorbed in healthy bodies, you won't be eligible if you have any specific medical conditions or are currently taking certain medications that could interfere with the study results.

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 with no serious medical conditions?
Are you prepared to take medicine on an empty stomach?
Are you able to visit a clinic multiple times for assessments?
Are you comfortable with blood samples being taken?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to a clinic. You would be given the study medicine, lisdexamfetamine dimesylate 70mg, on an empty stomach. Over a period of time, healthcare professionals would collect blood samples to measure how the medicine is absorbed and leaves your body. You'd also have regular check-ups to make sure you're feeling well and to monitor any effects of the medicine. The total duration of your participation, including all visits and follow-up, would be explained in full detail by the study team.

Potential risks and benefits

The potential benefit of taking part in this study is contributing to important medical research that helps us understand medicines better, which can lead to improved treatments in the future. As with any medicine, there is a potential for side effects, even in healthy individuals. The study team will explain all known potential risks associated with lisdexamfetamine dimesylate. You will have a medical team closely monitoring your health throughout the study. Remember, you can choose to leave 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?

It's a medication that is being studied to understand how it works in the body. This study focuses on how it's absorbed.

Why is this study only for healthy people?

Researchers often start by studying medicines in healthy people to understand how the drug behaves normally, without any other health conditions influencing the results.

Will I get paid for taking part?

Information about payment or reimbursement for your time and travel will be provided by the study team when you inquire about participation.

How long will I need to be in the study?

The exact duration will depend on the study's design, including how many visits are needed and how long you're monitored after taking the medicine. The study team will give you a detailed timeline.

What does 'fasting conditions' mean?

It means you will be asked not to eat or drink anything (except water) for a certain number of hours before taking the study medicine, and potentially for a period afterwards, as instructed by the study team.