التفاصيل البيبلوغرافية
| العنوان: |
Effect of Single and Repeated Doses of Ketoconazole on the Pharmacokinetics of Roflumilast and Roflumilast N-Oxide. |
| المؤلفون: |
Lahu, Gezim1,2 gezim.lahu@nycomed.com, Huennemeyer, Andreas1, von Richter, Oliver1, Hermann, Robert3, Herzog, Rolf1, McCracken, Nigel1, Zech, Karl1 |
| المصدر: |
Journal of Clinical Pharmacology. Nov2008, Vol. 48 Issue 11, p1339-1349. 11p. 3 Charts, 3 Graphs. |
| مصطلحات موضوعية: |
*KETOCONAZOLE, *ANTIFUNGAL agents, *ANTI-inflammatory agents, *PHARMACOKINETICS, *DRUG metabolism, *CLINICAL pharmacology, *CLINICAL medicine |
| مستخلص: |
Effects of single and multiple doses of oral ketoconazole on roflumilast and its active metabolite, roflumilast N-oxide, were investigated in healthy subjects. In study 1, subjects (n = 26) received oral roflumilast 500 μg once daily for 11 days and a concomitant 200-mg single dose of ketoconazole on day 11. In study 2, subjects (n = 16) received oral roflumilast 500 μg on days 1 and 11 and a repeated dose of ketoconazole 200 mg twice daily from days 8 to 20. Coadministration of single-dose ketoconazole with steady-state roflumilast increased the AUC of roflumilast by 34%; Cmax was unchanged. For roflumilast N-oxide, AUC and Cmax decreased by 12% and 20%, respectively. Repeated doses of ketoconazole increased the AUC and Cmax of roflumilast by 99% and 23%, respectively; for roflumilast N-oxide, AUC was unchanged, and Cmax decreased by 38%. No clinically relevant adverse events were observed. Coadministration of ketoconazole and roflumilast does not require dose adjustment of roflumilast. [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
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