Comparative Bioavailability and Food Effect of Four Norucholic Acid Formulations (tablet, granule, capsule) in Healthy Adult Volunteers

The primary objective is to evaluate the pharmacokinetic profile of four noruric acid formulations (tablet, granule, and capsule) when administered under fed versus fasted conditions in healthy adult volunteers, thereby determining relative bioavailability and informing optimal dosing strategies in clinical practice.

The trial enrolled healthy volunteers of both sexes; however, the sponsor did not provide the total number of participants. The age range of the enrolled individuals was not specified in the available data. Selection criteria focused on individuals without known medical conditions, reflecting a population of generally healthy adults. No specific lifestyle requirements such as diet, physical activity level, or other habits were detailed, and the inclusion and exclusion criteria beyond health status were not disclosed.

The study is a phase 3, randomized, double‑blind, controlled trial evaluating the pharmacokinetic profile of four formulations of noruric acid (tablet, granule, capsule with and without food) in healthy adult volunteers. Participants undergo an initial screening visit to confirm eligibility, followed by a baseline visit where the assigned formulation is administered under fasting or fed conditions. Subsequent scheduled visits occur at predetermined intervals to collect blood samples for absorption analysis, monitor safety parameters, and assess tolerability, culminating in an end‑of‑study visit that includes final assessments and study drug cessation. Individual involvement spans approximately six weeks from the first dose to the final evaluation, with the overall trial recruitment period projected from July 1 2026 to October 28 2026. Early termination may occur if a participant experiences a serious adverse event, withdraws consent, or fails to comply with the dosing schedule or study procedures.

The protocol does not specify any experimental medication, pharmaceutical form, dosage, route, or frequency of administration. No standard‑of‑care therapy, placebo, or comparator treatment is described. Consequently, no details regarding administration schedules or compliance monitoring are provided.