Palatability Assessment of Oral Dispersible Zonisamide Formulations in a Randomized, Open-Label, Three-Period Crossover Study with Healthy Volunteers

The primary objective of this study is to evaluate the **palatability** of oral dispersible formulations of **Zonisamide** in healthy volunteers. This is clinically relevant as palatability can significantly impact patient compliance, especially in populations such as pediatrics or those with swallowing difficulties. Ensuring that formulations are palatable can enhance adherence to medication regimens, thereby improving therapeutic outcomes. There are no secondary objectives listed for this study.

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, although specific age limits are not provided. The trial does not focus on a vulnerable population, indicating that the participants are generally in good health. The total number of participants is not disclosed, as the sponsor has not provided this information. Selection criteria for the trial population are not detailed, and there are no specific lifestyle considerations such as diet or physical activity mentioned. The absence of key inclusion or exclusion criteria suggests a broad recruitment strategy within the defined parameters of healthy adult volunteers.

The clinical trial is designed as a **randomized**, open-label, three-period crossover study to evaluate the palatability of oral dispersible formulations of **Zonisamide** in healthy volunteers. The trial is categorized under Phase 3, indicating it is in the later stages of clinical research. The estimated recruitment start date is June 23, 2025, with an anticipated end date of August 22, 2025, suggesting a total trial duration of approximately two months. Participants will be involved in the study for the entire duration unless early termination is warranted due to adverse events or non-compliance with study protocols.

The sequence of study visits begins with an inclusion visit, where potential participants undergo screening to ensure they meet the eligibility criteria. This visit is crucial for confirming the health status of volunteers and their suitability for the trial. Following successful inclusion, participants will proceed to the intervention phase, which involves three separate periods where they will receive different formulations of the study drug. Each period is followed by a washout phase to prevent carryover effects between treatments. Follow-up visits are scheduled to monitor the participants' health and gather data on the palatability of the formulations. The end-of-study visit marks the conclusion of the participant's involvement, where final assessments are conducted to ensure the safety and well-being of the volunteers.

Participants are expected to adhere to the study schedule and protocol requirements throughout their involvement. Conditions that may lead to early termination include the occurrence of significant adverse events, withdrawal of consent, or any deviation from the study protocol that could impact the integrity of the trial data. The study aims to provide valuable insights into the palatability of Zonisamide formulations, contributing to the optimization of its administration in clinical settings.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is provided in the available data. Consequently, a detailed description of the experimental treatment cannot be formulated based on the current dataset.

Similarly, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Therefore, a description of these elements is not possible with the given data.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also absent from the provided data. As such, no further details can be included in this description.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 3 study, indicating a focus on confirming effectiveness, monitoring side effects, and collecting information that will allow the treatment to be used safely. The trial is scheduled to commence recruitment on June 23, 2025, with an estimated end date of August 22, 2025. Efficacy assessments will be conducted at predetermined intervals throughout the trial duration, although specific timepoints and methods for measuring efficacy parameters are not detailed in the provided data. The trial will adhere to rigorous standards typical of Phase 3 studies to ensure the reliability and validity of the efficacy data collected.