Evaluation of Food Impact on Silexan 80 mg Pharmacokinetics in a Randomized, Open-Label, Crossover Study with Healthy Volunteers

The primary objective of this study is to evaluate the effect of food on the **pharmacokinetics** of Silexan 80 mg in healthy participants. Understanding the impact of food intake on the absorption, distribution, metabolism, and excretion of Silexan is clinically relevant as it can inform dosing recommendations and optimize therapeutic efficacy. The study involves a randomized, open-label, two-period, two-sequence crossover design to ensure comprehensive assessment of the pharmacokinetic profile under fed and fasting conditions.

The clinical trial involves **healthy volunteers** as the study population, encompassing both male and female participants. The age range of the participants is categorized as adults, specifically between 18 to 65 years. The trial population includes individuals who are not part of any vulnerable groups. However, the total number of participants has not been disclosed by the sponsor. The selection process for the trial population is not detailed, and there is no specific information provided regarding lifestyle considerations such as diet, physical activity, or habits. The sponsor has not provided key inclusion or exclusion criteria for this study.

The clinical trial is designed as a **randomized**, open-label, two-period, two-sequence crossover study aimed at investigating the effect of food on the pharmacokinetics of Silexan 80 mg in **healthy volunteers**. The trial is categorized under Phase 3 and is expected to commence recruitment on February 1, 2025, with an estimated completion date of April 30, 2025. Participants will be involved in the study for a duration that aligns with the trial's crossover design, which typically involves two separate periods of treatment with a washout phase in between.

The sequence of study visits begins with an inclusion visit, where potential participants undergo screening to determine eligibility based on predefined criteria. Following successful screening, participants will be randomized into one of two sequences, each involving two treatment periods. Each treatment period will be separated by a washout phase to ensure no carryover effects between treatments. During each period, participants will receive Silexan 80 mg under different conditions (e.g., with or without food) to assess the pharmacokinetic profile. Follow-up visits will be scheduled to monitor participants' health and collect necessary data. The end-of-study visit will conclude the trial, where final assessments are conducted, and participants are debriefed.

Participant involvement is expected to last until the completion of both treatment periods and the end-of-study visit. However, conditions such as adverse events, non-compliance with study procedures, or withdrawal of consent may lead to early termination from the study. The trial's design ensures that data collected will provide insights into the impact of food on the pharmacokinetics of Silexan, contributing to the understanding of its optimal use in clinical settings.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to begin recruitment on February 1, 2025, with an estimated end date of April 30, 2025. The efficacy assessment will be conducted using predefined primary and secondary endpoints, although specific endpoints are not detailed in the provided data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The efficacy parameters will be measured at various timepoints throughout the study, utilizing appropriate tools and instruments to ensure accuracy and reliability. The data collected will be analyzed to determine the efficacy of the intervention under investigation, adhering to rigorous clinical trial standards.