Evaluation of Oral and Buccal Absorption of Hydrocortisone from 2D-Printed Dissolvable Films in Healthy Volunteers and Adults with Adrenal Insufficiency

The primary objective of the study is to evaluate the differences in **absorption** of hydrocortisone when administered via the oral route compared to the oral mucosa using 2-dimensionally printed dissolvable films. This investigation is conducted in both healthy volunteers and adult patients with **adrenal insufficiency**. Understanding these differences is clinically relevant as it may inform optimal administration routes for hydrocortisone, potentially improving therapeutic outcomes for patients with adrenal insufficiency.

The clinical trial focuses on participants diagnosed with **adrenal insufficiency**. The study population includes both male and female subjects, encompassing a broad age range from children to adults. The trial involves a vulnerable population, indicating that special considerations are in place to ensure participant safety and ethical conduct. However, the sponsor has not provided information regarding the total number of participants involved in the study. The selection criteria for the trial population, as well as any specific lifestyle considerations such as diet or physical activity, have not been disclosed. Key inclusion or exclusion criteria are also not specified by the sponsor.

The clinical trial is designed to evaluate the differences in absorption of **hydrocortisone** when administered via oral route compared to oral mucosa using 2-dimensionally printed dissolvable films. This study will involve both healthy volunteers and adult patients diagnosed with **adrenal insufficiency**. The trial is structured as a Phase 2 study, which typically focuses on assessing the efficacy and side effects of the treatment. The trial is expected to commence recruitment on May 1, 2025, and is projected to conclude by June 30, 2026.

The trial will employ a randomized, double-blind, controlled design to ensure the reliability and validity of the results. Participants will be randomly assigned to different treatment groups, and neither the participants nor the investigators will know which treatment the participants are receiving, thus minimizing bias. The study will include several key visits: an initial screening visit to determine eligibility, multiple follow-up visits to monitor progress and collect data, and a final end-of-study visit to assess overall outcomes and gather final data.

Participant involvement is expected to last throughout the duration of the trial, from the initial screening to the end-of-study visit. However, certain conditions may lead to early termination from the study, such as adverse reactions to the treatment, non-compliance with study protocols, or withdrawal of consent by the participant. The study aims to provide valuable insights into the absorption characteristics of hydrocortisone, potentially informing future treatment strategies for individuals with adrenal insufficiency.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

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. Consequently, no description of these treatments can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be offered regarding these aspects of the clinical trial.

The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to commence recruitment on May 1, 2025, with an estimated completion date of June 30, 2026. 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 clinical standards to evaluate the therapeutic impact of the investigational product. The trial's design and execution will be aligned with regulatory requirements to ensure the reliability and validity of the efficacy outcomes.