Evaluation of Food Effect on Pharmacokinetics of Mesalazine Oral Formulation in Healthy Volunteers with Ulcerative Colitis

The primary objective of this study is to evaluate the **food effect** on the pharmacokinetics of a mesalazine oral formulation in healthy volunteers. Understanding the impact of food on the absorption and metabolism of mesalazine is clinically relevant, as it can influence the drug's efficacy and safety profile in the management of **ulcerative colitis**. This information is crucial for optimizing dosing regimens and improving therapeutic outcomes for patients with this condition.

The clinical trial focuses on participants diagnosed with **ulcerative colitis**. The study population includes both male and female subjects, with an age range categorized under code "3", which typically represents adults. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. Selection criteria, including any lifestyle considerations such as diet or physical activity, have not been disclosed. The absence of specific inclusion or exclusion criteria suggests a broad approach to participant selection, although detailed criteria are not available from the sponsor.

The clinical trial is designed to evaluate the **food effect** on the pharmacokinetics of an oral formulation of mesalazine in healthy volunteers. This study is a Phase 3 trial, which is expected to commence recruitment on December 9, 2024, and conclude by March 13, 2025. The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. Participants will be randomly assigned to different groups to receive the investigational product or a control, with neither the participants nor the investigators aware of the group assignments, thus maintaining the double-blind nature of the study.

The sequence of study visits begins with an inclusion visit, also known as the screening visit, where potential participants are assessed for eligibility based on predefined criteria. This visit is crucial for ensuring that only suitable candidates are enrolled in the trial. Following successful screening, participants will undergo a series of follow-up visits, which are scheduled at regular intervals to monitor their health status, adherence to the study protocol, and any adverse events. These visits are essential for collecting data on the pharmacokinetics of mesalazine under different dietary conditions. The trial will culminate in an end-of-study visit, where final assessments are conducted, and participants are debriefed about the study.

The expected length of participant involvement in the trial is determined by the study protocol, which outlines the duration of each phase and the total time commitment required. Participants may be subject to early termination from the study if they experience significant adverse effects, fail to comply with the study protocol, or withdraw consent. Such conditions are clearly defined to ensure participant safety and the integrity of the trial data. The study is focused on understanding the impact of food on mesalazine pharmacokinetics, which is relevant for optimizing treatment strategies for conditions such as **ulcerative colitis**.

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

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

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. As such, these aspects cannot be detailed in this description.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on December 9, 2024, with an estimated completion date of March 13, 2025. The efficacy assessment will be conducted through a series of pre-defined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The study will adhere to rigorous standards typical of Phase 3 trials, focusing on evaluating the treatment's effectiveness in a larger patient population. The trial's design will likely incorporate validated scales, laboratory tests, or patient-reported outcomes to measure efficacy, consistent with standard practices in clinical research. The absence of specific endpoints in the provided data suggests that these details will be outlined in the full trial protocol, ensuring comprehensive evaluation of the treatment's impact on the targeted medical condition.