{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,6]],"date-time":"2026-06-06T15:48:39Z","timestamp":1780760919584,"version":"3.54.1"},"reference-count":35,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2024,9,12]],"date-time":"2024-09-12T00:00:00Z","timestamp":1726099200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Budesonide oral suspension (BOS) is a swallowed corticosteroid indicated for 12\u2010week therapy in eosinophilic esophagitis with minimal systemic exposure following administration. We aimed to assess the relative bioavailability of a single dose of BOS administered under fasting and fed (high\u2010fat\/high\u2010calorie meal) conditions. Healthy adult volunteers (N = 20) were enrolled in an open\u2010label, single\u2010center, crossover study and were randomized (1:1) to receive a single oral dose of BOS 2.0 mg under fasting or fed conditions, with a 48\u2010h washout period before crossover to the alternative conditions. Serial plasma samples were collected before and up to 24 h after dosing. Pharmacokinetic (PK) parameters were calculated from plasma budesonide concentration\u2013time profiles by noncompartmental analysis. The mean peak budesonide concentration (C<jats:sub>max<\/jats:sub>) was \u223c13% lower under fed than under fasting conditions (604.1 vs 692.9 pg\/mL). Areas under the concentration\u2013time curves from dosing to the last measurable budesonide concentration and from dosing to infinity were \u223c26% higher and \u223c27% higher under fed than fasting conditions (3529 vs 2811 pg h\/mL and 3892 vs 3075 pg h\/mL, respectively). The median time to peak plasma budesonide concentration was significantly longer (\u223c1 h) under fed than fasting conditions (2.516 vs 1.286 h, <jats:italic>P<\/jats:italic> &lt;\u00a0.001). Safety and tolerability were also assessed throughout the study; all adverse events were mild or moderate in severity. Despite slight differences in budesonide PK parameters between fed and fasting conditions, the effect of food on systemic exposure to budesonide (BOS formulation) is not expected to be clinically meaningful.<\/jats:p>","DOI":"10.1002\/jcph.6131","type":"journal-article","created":{"date-parts":[[2024,9,12]],"date-time":"2024-09-12T13:19:41Z","timestamp":1726147181000},"page":"217-225","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Effect of Food on the Pharmacokinetics, Safety, and Tolerability of Budesonide Oral Suspension in Healthy Adult Participants: A Randomized Phase 1 Study"],"prefix":"10.1002","volume":"65","author":[{"given":"Alexander J.","family":"Prokopienko","sequence":"first","affiliation":[{"name":"Takeda Development Center Americas, Inc.  Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junyao","family":"Wang","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc.  Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vijay","family":"Yajnik","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceuticals USA, Inc.  Lexington MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mike","family":"Baratta","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc.  Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nirav K.","family":"Desai","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc.  Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Camilla A.","family":"Richmond","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc.  Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ajit","family":"Suri","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc.  Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,9,12]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2018.07.009"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1097\/PAS.0000000000001361"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2023.06.005"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/nmo.12323"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.13370"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2017.06.036"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1502863"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40272-020-00398-z"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2020.02.038"},{"issue":"2","key":"e_1_2_10_11_1","first-page":"106","article-title":"Emerging therapeutic options for eosinophilic esophagitis","volume":"10","author":"Dougherty T","year":"2014","journal-title":"Gastroenterol Hepatol (N Y)"},{"key":"e_1_2_10_12_1","unstructured":"Takeda Pharmaceuticals America Inc.Highlights of prescribing information EOHILIA 2024. US FDA. Accessed May 31 2024.https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2024\/213976s000lbl.pdf"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2016.11.021"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.17430"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.17554\/j.issn.2224-3992.2018.07.750"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1097\/MPG.0000000000003482"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40268-020-00324-1"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.14309\/01.ajg.0000703808.97523.a5"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2036.2001.00910.x"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2036.2003.01426.x"},{"key":"e_1_2_10_21_1","unstructured":"Salix Pharmaceuticals Inc. a division of Bausch Health US LLC.Uceris\u00ae (budesonide) extended\u2010release tablets. Prescribing information.2020. Accessed May 31 2024.https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/203634s007lbl.pdf"},{"key":"e_1_2_10_22_1","unstructured":"AstraZeneca.Entocort EC (budesonide) delayed\u2010release capsules. Prescribing information.2020. Accessed May 31 2024.https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/021324s023lbl.pdf"},{"key":"e_1_2_10_23_1","unstructured":"US Food and Drug Administration.Assessing the effects of food on drugs in INDs and NDAs \u2014 clinical pharmacology considerations. Guidance for industry.2022. Accessed May 31 2024.https:\/\/www.fda.gov\/downloads\/drugs\/guidancecomplianceregulatoryinformation\/guidances\/ucm070241.pdf"},{"key":"e_1_2_10_24_1","unstructured":"ClinicalTrials.gov.An extension study to evaluate maintenance of efficacy and long\u2010term treatment effect of oral budesonide suspension (OBS) in adults and adolescents with eosinophilic esophagitis (EoE) (ORBIT2). 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