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Because patients with fistulizing Crohn's disease benefit by using high doses of metronidazole for prolonged periods, this study's primary aim was to evaluate the effect of high\u2010dose metronidazole on the pharmacokinetics of oral budesonide, a sensitive substrate of CYP3A commonly prescribed in acute inflammatory bowel disease. Twelve healthy adults received 1.5 g metronidazole per day over 1 week. The CYP3A\u2010dependent metabolic profile of an oral dose of budesonide (3 mg) and that of endogenous cortisol were compared intraindividually before and after administration of metronidazole. There was neither a significant effect of high\u2010dose metronidazole on the area under the plasma concentration\u2010time curve (AUC) of budesonide (90% confidence interval, 79%\u2013115%) nor on the AUC ratios of 6\u03b2\u2010hydroxybudesonide\/budesonide and 16\u03b1\u2010hydroxyprednisolone\/budesonide. In parallel, metronidazole did not significantly alter formation of 6\u03b2\u2010hydroxycortisol. Vice versa, budesonide did not affect the AUC of metronidazole (90% confidence interval, 91%\u2013100%). The authors conclude that in contrast to concomitant intake of other imidazoles such as ketoconazole, concomitant intake of metronidazole may not lead to serious safety concerns due to elevated systemic concentrations of the glucocorticoid budesonide.<\/jats:p>","DOI":"10.1177\/0091270007308617","type":"journal-article","created":{"date-parts":[[2007,11,29]],"date-time":"2007-11-29T18:48:43Z","timestamp":1196362123000},"page":"1532-1539","source":"Crossref","is-referenced-by-count":11,"title":["Effect of High\u2010Dose Metronidazole on Pharmacokinetics of Oral Budesonide and Vice Versa: A Double Drug Interaction Study"],"prefix":"10.1002","volume":"47","author":[{"given":"Karin","family":"Dilger","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard","family":"Fux","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"R\u00f6ck","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Klaus","family":"M\u00f6rike","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christop H.","family":"Gleiter","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2013,3,7]]},"reference":[{"key":"e_1_2_5_2_2","doi-asserted-by":"publisher","DOI":"10.1067\/mcp.2001.116891"},{"key":"e_1_2_5_3_2","doi-asserted-by":"publisher","DOI":"10.1146\/annurev.pharmtox.39.1.1"},{"key":"e_1_2_5_4_2","doi-asserted-by":"publisher","DOI":"10.1146\/annurev.pharmtox.38.1.389"},{"key":"e_1_2_5_5_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1990.03450210088038"},{"key":"e_1_2_5_6_2","doi-asserted-by":"publisher","DOI":"10.1155\/2006\/250490"},{"key":"e_1_2_5_7_2","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-200038010-00003"},{"key":"e_1_2_5_8_2","doi-asserted-by":"publisher","DOI":"10.1096\/fasebj.6.2.1371482"},{"key":"e_1_2_5_9_2","doi-asserted-by":"publisher","DOI":"10.1007\/s002280000201"},{"key":"e_1_2_5_10_2","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1E399"},{"key":"e_1_2_5_11_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1540-8159.2005.09348.x"},{"key":"e_1_2_5_12_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2006.02771.x"},{"key":"e_1_2_5_13_2","unstructured":"USFoodandDrug Administration.Guidance for Industry: Drug Interaction Studies\u2014Study Design Data Analysis and Implications for Dosing and Labeling. 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