Bioequivalence of Generic Fexofenadine HCl/Pseudoephedrine HCl Extended‑Release 180 mg/240 mg Tablet versus Reference Formulation in Healthy Adults under Fed Conditions (Seasonal Allergic Rhinitis)

The primary objective is to determine the bioequivalence of the test fexofenadine/pseudoephedrine extended‑release tablet relative to the reference product in healthy adults under fed conditions, using standard pharmacokinetic metrics such as maximum concentration (Cmax) and area under the concentration‑time curve (AUC).

Secondary objectives include evaluation of safety and tolerability through monitoring of adverse events and clinical laboratory parameters, and characterization of additional pharmacokinetic endpoints such as time to maximum concentration (Tmax) and elimination half‑life.

The trial enrolled individuals of both sexes, including participants classified as vulnerable, drawn from a cohort of healthy volunteers. Subjects were identified as having Seasonal allergic rhinitis. The sponsor did not provide the total number of enrolled participants, as the reported subject count is zero. Age eligibility was indicated by an internal code “3”, but specific age limits were not disclosed. Selection criteria encompassed general health status consistent with inclusion of otherwise healthy individuals, while no detailed lifestyle restrictions such as diet or physical activity were reported.

The study is a Phase 2, open‑label, balanced, randomized, single‑dose, two‑treatment, two‑period, two‑sequence crossover bioequivalence trial conducted in healthy adult volunteers under fed conditions. After an initial screening visit to confirm eligibility, participants are randomly assigned to one of two treatment sequences and receive a single oral dose of either the investigational Fexofenadine HCl/Pseudoephedrine HCl extended‑release tablet (180 mg/240 mg) or the reference Allegra‑D® 24 HR tablet. Following each dosing period, safety and pharmacokinetic assessments are performed, after which a washout interval is observed before crossover to the alternate treatment. Subsequent follow‑up visits include blood sampling for pharmacokinetic analysis and safety monitoring, culminating in an end‑of‑study visit that completes the final assessments. Participant involvement spans the screening, two dosing periods with intervening washout, and all follow‑up visits, typically lasting several weeks. Early termination may occur if a participant experiences a serious adverse event, violates key inclusion/exclusion criteria, or withdraws consent.