AuthorisedHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A Randomized, Multiple-Dose, Open-Label, Parallel-Group Study to Evaluate the Pharmacokinetic Profiles of LY03010 and the Relative Bioavailability at Steady-State of LY03010 versus XEPLION® in Patients with Schizophrenia

This research is investigating a new form of medication for people living with schizophrenia. The main goal is to understand how the body processes this new medication (called LY03010) over time, and whether it performs similarly to an already approved medication called XEPLION®. Researchers will give participants multiple doses of either the new medication or the existing one. This type of study, often called a bioequivalence study, helps determine if a new drug can be used in the same way as an established one. It's an early-stage study, focusing on how the drug behaves in the human body.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Geneora Pharma (Shijiazhuang) Co. Ltd.

Enrolment target

170

Start

04 Apr 2024

Schizophrenia

What is this study about?

Imagine you have a key that opens a lock. This study is like checking if a different, slightly updated version of that key still opens the same lock just as well. Specifically, this research is looking into a new medication for schizophrenia, which is a condition that affects how a person thinks, feels, and behaves. The new medication is called LY03010.

The main purpose of this study is to compare LY03010 with an existing and approved medication called XEPLION®. The research wants to see if, after taking multiple doses, the new medication is processed by the body in a very similar way to the existing one. This is important because if they are similar, it could mean the new medication might be an alternative option for treatment.

This is an early-stage study, sometimes called a Phase 1 or 'human pharmacology' study. This means it's one of the first times the medication is being closely studied in people, with a focus on how it moves through and is handled by the body, rather than on its long-term effects. The results will help doctors and scientists understand if this new medication could be a good choice for future studies and, eventually, for patients.

Key takeaways

This study is testing a new medication (LY03010) for schizophrenia.
It compares the new medication to an existing one (XEPLION®) to see how the body handles both.
The goal is to check if the new medication works similarly to the existing one in the body.
It's an early-stage study focused on how the medication behaves in humans.
Participants must be 18 or older; both men and women can take part.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. There is no upper age limit mentioned, so adults of any age might be able to take part.

Both men and women are welcome to participate in this research. The study aims to include a diverse group of people to get a broad understanding of how the medication works across different individuals.

There may be other specific health requirements or conditions that would determine if this study is right for you, but these are not detailed in the information provided. Your doctor or the study team would discuss all these details with you if you express interest.

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 living with schizophrenia?
Are you comfortable knowing which medication you are receiving during the study (it's 'open-label')?
Are you able to attend appointments for blood tests and other assessments?

Answer every question to see your result.

What does participation involve?

The specific details of what your participation would involve, such as how many visits you would need to make, what assessments or tests would be done, and the exact length of the study, are not provided here. However, based on the type of study (pharmacokinetics and bioequivalence), you could expect that:

* **Medication:** You would receive doses of either the new medication (LY03010) or the existing medication (XEPLION®). * **Assessments:** There would likely be regular blood samples taken to measure how much of the medication is in your system. Other tests might include checking your vital signs (like blood pressure and heart rate) and general health. * **Duration:** You would receive multiple doses, and there would be follow-up appointments after the last dose. The full duration of your participation would be explained by the study team. * **Open-Label:** This means both you and the study team will know which medication you are receiving.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit could be contributing to scientific understanding that might lead to new or improved treatments for schizophrenia. You would also receive close medical attention during the study. Potential risks could include side effects from the study medication, which the medical team would explain fully, or discomfort from procedures like blood draws. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

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

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Unverified
Bulgaria
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Unverified
Croatia
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Unverified
Portugal

Common questions

What is 'schizophrenia'?

Schizophrenia is a long-term mental health condition that can cause a range of psychological symptoms, including experiencing hallucinations, delusions, and confused thoughts and speech. It affects how a person thinks, feels, and behaves.

What does 'pharmacokinetic profiles' mean?

This basically means how the body handles the medication. Researchers look at how the drug is absorbed into the bloodstream, how it's distributed around the body, how it's changed by the body, and how it leaves the body.

What is 'bioequivalence'?

Bioequivalence means that two different versions of a drug act in a very similar way in the body. If two drugs are bioequivalent, they can usually be used interchangeably, meaning they have the same effects.

What is an 'open-label' study?

An open-label study means that everyone involved – both you as the participant and the doctors/nurses running the study – will know which specific medication you are receiving.

Will I get paid for participating?

The information provided doesn't say if participants will be paid. If you are interested, this is a good question to ask the study team directly.