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- W1971448764 abstract "This open, randomized, single‐dose crossover study investigated effects of a high‐fat meal on the pharmacokinetics of roflumilast and its major active N‐oxide metabolite. Twelve healthy subjects received oral roflumilast 500 μg (2 × 250 μg) after overnight fasting and after breakfast. Blood was sampled up to 54 hours for pharmacokinetic profiling of roflumilast and N‐oxide. Geometric mean ratios (fed/fasted) for point estimates (PE) and 90% confidence intervals (CI) were calculated for AUC 0‐last , AUC 0‐∞ , and C max of both compounds. After the meal, roflumilast C max (PE, 0.59; 90% CI, 0.49‐0.70) was modestly reduced; N‐oxide C max (PE, 0.95; 90% CI, 0.90‐1.01) was unchanged. Roflumilast t max was delayed in fed state (2.0 ± 0.4 hours) versus fasted state (1.0 ± 0.2 hours); N‐oxide t max was unaltered. No significant food effect on roflumilast AUC 0‐last (PE, 1.04; 90% CI, 0.90‐1.21), AUC 0‐∞ (PE, 1.12; 90% CI, 1.00–1.25), and respective N‐oxide AUCs (PE, 0.91; 90% CI, 0.79‐1.04; PE, 0.99; 90% CI, 0.92‐1.06) occurred. Because roflumilast N‐oxide is the major contributor to roflumilast's overall pharmacologic effects, these findings suggest that roflumilast can be taken with or without food." @default.
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- W1971448764 date "2006-10-01" @default.
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- W1971448764 title "Investigation of a Potential Food Effect on the Pharmacokinetics of Roflumilast, an Oral, Once-Daily Phosphodiesterase 4 Inhibitor, in Healthy Subjects" @default.
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- W1971448764 doi "https://doi.org/10.1177/0091270006291621" @default.
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