Bioequivalence of a Generic Fexofenadine 180 mg/Pseudoephedrine 240 mg Extended‑Release Tablet Versus Allegra‑D 24 HR in Healthy Adults for Seasonal Allergic Rhinitis

The primary objective is to evaluate bioequivalence of the test fexofenadine hydrochloride/pseudoephedrine hydrochloride extended‑release tablet (180 mg/240 mg) relative to the reference product (Allegra‑D® 24 HR) in healthy adult participants under fasting conditions, by comparing pharmacokinetic parameters such as C_max and AUC to determine whether systemic exposure of the test formulation is equivalent to that of the reference, thereby supporting its potential interchangeability for the management of seasonal allergic rhinitis.

The sponsor did not provide the total number of participants. The trial enrolled both female and male individuals, including vulnerable subjects, who were classified as healthy volunteers and diagnosed with seasonal allergic rhinitis. The age range of the cohort was not specified in the available data. General health status was limited to the presence of the allergic condition, and no specific information on diet, physical activity, or other lifestyle factors was reported. Key inclusion criteria encompassed a confirmed diagnosis of the allergic condition and eligibility as a healthy volunteer, while exclusion criteria were not detailed in the source material.

The study is a Phase 2, open label, balanced, randomized, single‑dose, two‑treatment, four‑period, two‑sequence, crossover, fully replicate, bioequivalence trial comparing a test tablet containing fexofenadine hydrochloride and pseudoephedrine hydrochloride (180 mg/240 mg) with the reference product Allegra‑D® 24 HR in healthy adult volunteers under fasting conditions. After informed consent, participants undergo a screening visit to confirm eligibility, including assessment for seasonal allergic rhinitis exclusion criteria. Eligible subjects then enter four dosing periods separated by washout intervals; each period includes a pre‑dose assessment, administration of the assigned treatment, and serial pharmacokinetic sampling over the subsequent 24 hours. Follow‑up visits are scheduled at the end of each washout to monitor safety and collect residual data, and an end‑of‑study visit concludes the trial with final safety evaluations and study drug accounting. Individual participation spans approximately 4–6 weeks, encompassing all dosing and washout phases. Early termination may occur if a participant experiences a serious adverse event, violates major protocol requirements, or withdraws consent.