Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Lisdexamfetamine Dimesylate capsules 70 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Elvanse (lisdexamfetamine dimesylate) 70 mg hard capsules, Marketing Authorization Holder: Takeda Pharmaceuticals International AG Ireland Branch, Block 2, Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland, in healthy adult, human subjects under fasting condition.

This study is looking at a new version of a medicine for Attention Deficit Hyperactivity Disorder (ADHD), which is similar to a well-known one called Elvanse. Researchers want to check if this new medicine acts in the body in the exact same way as the original Elvanse. This type of study, called a 'bioequivalence' study, is really important. It helps make sure that any new generic versions of medicines are just as effective and safe as the original brand. Healthy adult volunteers will take part, and they will receive both the new medicine and Elvanse at different times to allow for a fair comparison.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Sun Pharmaceutical Industries Limited

Enrolment target

Start

28 Apr 2025

ADHD

What is this study about?

Imagine you have a branded medicine that works well for a condition like ADHD. Sometimes, other companies want to make their own versions of this medicine, often at a lower cost. Before these new versions can be used by patients, it's very important to make sure they work exactly the same way as the original.

This particular study is doing just that. It's comparing a new version of a medication called lisdexamfetamine dimesylate (the active ingredient in Elvanse) made by a company called Sun Pharmaceutical Industries with the original Elvanse capsules. The main goal is to see if the new version is 'bioequivalent' to Elvanse. This means checking if the new medicine gets into the body and reaches the bloodstream at the same rate and to the same extent as the original. If they are bioequivalent, it means they should have the same effects and be just as safe.

The study is designed to be very fair. Each healthy volunteer will try both medicines (the new one and Elvanse) at different times. This way, researchers can directly compare how each medicine behaves in the same person, giving a very clear picture of whether they are truly interchangeable.

Key takeaways

This study compares a new version of an ADHD medicine (like Elvanse) with the original.
It aims to ensure the new medicine works just as well and is as safe as the original.
Healthy adults (18+) are needed for this research.
Participants will receive a single dose of each medicine at different times, with monitoring.
It's a 'bioequivalence' study, designed to show if the medicines are interchangeable.
You can stop participating at any time if you change your mind.

Who may be eligible?

For this study, researchers are looking for healthy adults. To be considered, you must be 18 years old or older. There is no upper age limit mentioned, so older adults who are otherwise healthy could also be eligible. Both men and women can take part in this research.

Being 'healthy' for a study usually means you don't have any significant ongoing medical conditions that could interfere with how the medicine works or put your health at risk during the study. This would typically include not having serious heart, kidney, or liver problems, and not taking certain medications that could interact with the study drug.

The research team will carry out a full health check to make sure it's safe for you to participate. They will likely ask about your medical history, perform a physical exam, and take blood or urine samples to confirm you meet all the health requirements.

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 visit a clinic for several hours or overnight on multiple occasions?
Are you comfortable with having regular blood samples taken?
Are you currently not pregnant or breastfeeding (if applicable)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would visit the study clinic on several occasions. During one visit, you would receive the new version of the medicine, and during another visit, you would receive the original Elvanse, or vice versa. The order in which you receive the medicines will be randomly assigned, like flipping a coin, to ensure fairness.

Each time you take a dose, you would be asked to remain at the clinic for a period of time, typically several hours or even overnight. During this time, nurses or doctors would regularly take blood samples to measure how the medicine is absorbed and processed by your body. They would also monitor your general health and check for any side effects. You would receive a single dose of the medicine for each test period. The entire study involves two separate periods where you take medication, with a break in between. The total time you'd be actively involved in the study, including all visits and follow-ups, would be explained in detail by the study team.

Potential risks and benefits

Participating in a study like this could offer some potential benefits, such as contributing valuable information that helps bring new, potentially more affordable, versions of medicines to people with ADHD. You might also receive free health check-ups and medical monitoring during the study. However, there are potential risks, just like with any medicine. These could include minor side effects such as headache, nausea, or dizziness, or more serious but very rare side effects. The study team will carefully monitor you for any problems. Remember, taking part is completely voluntary, and 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
Romania

Common questions

What is 'bioequivalence'?

Bioequivalence means that two different versions of a medicine deliver the same amount of the active drug to your body at the same speed, so they should work in the same way.

Do I need to have ADHD to join this study?

No, this study is looking for healthy adults, not people with ADHD. It's to test how the medicine behaves in the body generally.

Will I know if I'm getting the new medicine or Elvanse?

Usually in these types of studies, you wouldn't know which one you're taking at a given time. This helps keep the results fair and unbiased.

How long will I be at the clinic after taking the medicine?

After taking the medicine, you'll likely need to stay at the clinic for several hours or sometimes overnight for blood tests and monitoring. The exact duration will be explained by the study team.

Will I get paid for taking part?

Many clinical trials offer some payment for your time and inconvenience. This would be clearly explained by the study team before you agree to take part.