Single-dose and steady-state bioequivalence of fexofenadine and pseudoephedrine combination tablets compared with individual formulations in healthy adults.

Objective: A 24-h extended-release formulation of fexofenadine HCl 180 mg/pseudoephedrine HCl 240 mg (FEX 180 mg/PSE 240 mg) has recently been approved by the US Food and Drug Administration for symptom relief of seasonal allergic rhinitis, including nasal congestion. When considering a combination formulation, it is important to confirm that the metabolism and pharmacokinetics of the drugs remain unchanged when combined. Thus, the aim of this study was to evaluate single-dose and steady-state bioequivalence of FEX 180 mg/PSE 240 mg 24-h compared with the individual formulations taken concurrently.