J Clin Pharmacol
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DRUG INTERACTIONS

The Oral, Once-Daily Phosphodiesterase 4 Inhibitor Roflumilast Lacks Relevant Pharmacokinetic Interactions With Inhaled Budesonide

Robert Hermann, MD, Werner Siegmund, MD, Thomas Giessmann, MD, Kristin Westphal, MD, Anita Weinbrenner, MD, Bernhard Hauns, MD, Felix Reutter, PhD, Gezim Lahu, Karl Zech, PhD and Thomas D. Bethke, MD

From ALTANA Pharma AG, Konstanz, Germany (Dr Hermann, Dr Hauns, Mr Lahu, Dr Zech, and Dr Bethke); the Department of Clinical Pharmacology, University of Greifswald, Greifswald, Germany (Dr Siegmund, Dr Giessmann, Dr Westphal, and Dr Weinbrenner); and ALTANA Pharma Pvt Ltd, Mumbai, India (Dr Reutter).

This open-label, randomized, 3-period crossover study evaluated the pharmacokinetic interaction potential of roflumilast and budesonide following repeated coadministration to healthy male subjects (N = 12). Treatments consisted of oral roflumilast 500 µg, once daily, orally inhaled budesonide 800 µg, twice daily, and concomitant administration of both treatments for 7 days each. Roflumilast and roflumilast N-oxide in plasma and budesonide serum levels were measured by specific assays. Geometric mean test/reference ratios of steady-state pharmacokinetic parameters were evaluated by analysis of variance. Safety and tolerability were monitored. Pharmacokinetic parameters of roflumilast, roflumilast N-oxide, and budesonide after coadministration of roflumilast and budesonide were similar to those after mono-treatment. Compared with budesonide and roflumilast mono-treatments, slightly lower maximum serum/plasma concentration (Cmax) and area under the curve (AUC) values of roflumilast N-oxide and budesonide (ranging from -8% to -16%) were observed with combined treatment. All test/reference ratios were within predefined equivalence acceptance ranges for roflumilast AUC (0.80, 1.25) and Cmax (0.70, 1.43) and for roflumilast N-oxide and budesonide AUC and Cmax (all 0.67, 1.50). Coadministration of roflumilast and budesonide did not alter the steady-state disposition of each other and did not affect safety and tolerability of either drug.

Key Words: Budesonide • Pulmicort® Turbuhaler® • roflumilast • pharmacokinetics • PDE4 inhibitor

Address for correspondence: Thomas D. Bethke, MD, Nycomed Deutschland GmbH, Moltkestr. 4, 78467 Konstanz, Germany.


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