Pharmacokinetic Comparison of Oral Budesonide Formulations With and Without Food in Patients With Acute Eosinophilic Esophagitis

The primary objective is to assess the pharmacokinetic profile of budesonide after oral administration of different dosage forms under fed and fasted conditions in individuals with acute eosinophilic esophagitis, thereby determining the influence of food on systemic drug exposure.

The trial enrolled individuals with a diagnosis of eosinophilic esophagitis. Both female and male participants were eligible, and the enrollment included individuals classified as vulnerable. Enrolled subjects were categorized as healthy volunteers. Specific age limits, total participant count, and detailed lifestyle attributes such as diet, physical activity, or habits were not disclosed by the sponsor; consequently, the sponsor did not provide this information.

The study is a Phase 3 trial evaluating the oral absorption of budesonide from different formulations administered with and without food in participants diagnosed with acute eosinophilic esophagitis. After an initial screening visit to confirm eligibility, eligible individuals will undergo a baseline assessment followed by administration of the assigned study medication. Participants will attend scheduled follow‑up visits to monitor drug uptake, safety parameters, and clinical outcomes throughout the treatment period, concluding with an end‑of‑study visit for final assessments. The overall involvement for each participant is expected to span the duration of the treatment and follow‑up phases, encompassing approximately several weeks to months, within the trial window from July 2026 to June 2027. Early termination may occur if predefined safety criteria are met, if the participant withdraws consent, or if protocol non‑compliance renders continued participation infeasible.

Efficacy of the investigational product in subjects with Acute eosinophilic esophagitis will be evaluated in accordance with the predefined study protocol.