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This concentration was at least 8 times the therapeutic plasma concentration in man (based on a 180 mg once daily fexofenadine hydrochloride dose). No statistically significant increase in mean QTc interval compared to placebo was observed in 714 subjects with seasonal allergic rhinitis given fexofenadine hydrochloride capsules in doses of 60 mg to 240 mg twice daily for 2 weeks or in 40 healthy volunteers given fexofenadine hydrochloride as an oral solution at doses up to 400 mg twice daily for 6 days. A 1-year study designed to evaluate safety and tolerability of 240 mg of fexofenadine hydrochloride (n240) compared to placebo (n237) in healthy volunteers, did not reveal a statistically significant increase in the mean QTc interval for the fexofenadine hydrochloride treated group when evaluated pretreatment and after 1, 2, 3, 6, 9, and 12 months of treatment. Administration of the 60 mg fexofenadine hydrochloride120 mg pseudoephedrine hydrochloride combination tablet for approximately 2 weeks to 213 subjects with seasonal allergic rhinitis demonstrated no statistically significant increase in the mean QTc interval compared to fexofenadine hydrochloride administered alone (60 mg twice daily, n215), or compared to pseudoephedrine hydrochloride (120 mg twice daily, n215) administered alone.

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