{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,27]],"date-time":"2026-05-27T17:39:07Z","timestamp":1779903547359,"version":"3.53.1"},"reference-count":28,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2022,5,8]],"date-time":"2022-05-08T00:00:00Z","timestamp":1651968000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2022,5,8]],"date-time":"2022-05-08T00:00:00Z","timestamp":1651968000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["bpspubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacology Res &amp; Perspec"],"published-print":{"date-parts":[[2022,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Patients with osteoporosis often take oral bisphosphonates with food, rendering these medications ineffective. This study compared the relative absorption of four formulations of gastro\u2010resistant (GR; formulations 1\u20134) risedronate 35\u00a0mg versus immediate\u2010release (IR) risedronate 35\u00a0mg taken fasted. Secondarily, it compared the relative absorption of GR formulations administered fed and fasted, and determined the site of disintegration. Healthy participants (\n                    <jats:italic>N<\/jats:italic>\n                    \u00a0=\u00a0160) were randomized to one of nine treatment groups: IR risedronate taken fasted (group A) or formulations 1\u20134 taken fasted or fed (groups B\u2013I). Fasted groups fasted for 8\u00a0h pre\u2010dose and 4\u00a0h post\u2010dose. Fed groups fasted for 7.5\u00a0h, then took risedronate with breakfast. Urine was collected until 72\u00a0h post\u2010dose and analyzed using liquid chromatography. From each group, up to seven participants underwent scintigraphic monitoring to assess tablet disintegration. The percentage of total dose recovered in urine (A\u2019\n                    <jats:sub>e<\/jats:sub>\n                    ) was ~0.5% for group A. The A\u2019\n                    <jats:sub>e<\/jats:sub>\n                    of formulations 1\u20134 taken fasted was 0.220% (90% confidence interval 0.124\u20130.389), 0.298% (0.122\u20130.730), 0.154% (0.090\u20130.264), and 0.108% (0.051\u20130.231), respectively. With food, the A\u2019\n                    <jats:sub>e<\/jats:sub>\n                    of formulation 1 decreased least versus fasted (\u221227%) compared with the A\u2019\n                    <jats:sub>e<\/jats:sub>\n                    of formulations 2, 3, and 4 (\u221273%, \u221280%, and \u221265%, respectively). Formulations 1\u20133 disintegrated in the small intestine, formulation 4 closer to the large intestine. All GR formulations were well tolerated and in line with the known safety profile for IR risedronate. Formulation 2 had the highest absorption when taken fasted, whereas the absorption of formulation 1 was least affected by food.\n                  <\/jats:p>","DOI":"10.1002\/prp2.957","type":"journal-article","created":{"date-parts":[[2022,5,8]],"date-time":"2022-05-08T04:54:52Z","timestamp":1651985692000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["An open\u2010label randomized study of the relative absorption of gastro\u2010resistant risedronate taken fasted or with food versus immediate\u2010release risedronate"],"prefix":"10.1002","volume":"10","author":[{"given":"Diane","family":"Kleinermans","sequence":"first","affiliation":[{"name":"Formerly Covance Clinical Research Unit Ltd  Leeds UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Joyson","sequence":"additional","affiliation":[{"name":"Formerly Pharmaceutical Profiles Ltd  Ruddington UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2969-3192","authenticated-orcid":false,"given":"Heather","family":"Wray","sequence":"additional","affiliation":[{"name":"Formerly Pharmaceutical Profiles Ltd  Ruddington UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,5,8]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.7326\/M15\u20101361"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11657\u2010020\u20100706\u2010y"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11657\u2010017\u20100324\u20105"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00198\u2010018\u20104704\u20105"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.282.14.1344"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s001980050010"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11657\u2010018\u20100439\u20103"},{"key":"e_1_2_13_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00198\u2010013\u20102332\u20107"},{"key":"e_1_2_13_10_1","doi-asserted-by":"publisher","DOI":"10.1023\/A:1011024200280"},{"key":"e_1_2_13_11_1","doi-asserted-by":"publisher","DOI":"10.2147\/TCRM.S52291"},{"key":"e_1_2_13_12_1","doi-asserted-by":"publisher","DOI":"10.18553\/jmcp.1998.4.5.488"},{"key":"e_1_2_13_13_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365\u20102125.1999.00035.x"},{"key":"e_1_2_13_14_1","unstructured":"Accord Healthcare UK.Alendronic acid 10 mg tablets summary of product characteristics."},{"key":"e_1_2_13_15_1","unstructured":"Consilient Health.Ibandronic acid 150 mg tablets summary of product characteristics."},{"key":"e_1_2_13_16_1","unstructured":"Accord Healthcare UK.Risedronate sodium 5 mg tablets summary of product characteristics."},{"key":"e_1_2_13_17_1","doi-asserted-by":"publisher","DOI":"10.3109\/13697137.2014.995164"},{"key":"e_1_2_13_18_1","doi-asserted-by":"publisher","DOI":"10.1586\/14737167.2016.1171145"},{"key":"e_1_2_13_19_1","unstructured":"SunL BurgioD SchnellD ThomasP&DunlapLAn open\u2010label single\u2010center single\u2010dose randomized parallel\u2010group study to compare absorption of risedronate 50 mg in healthy volunteers following oral administration of an immediate\u2010release tablet or an EnterionTMcapsule with delivery to the ascending colon. Procter & Gamble Pharmaceuticals. 2004.Study number 2004035 data on file."},{"key":"e_1_2_13_20_1","doi-asserted-by":"publisher","DOI":"10.1093\/nar\/gkx1121"},{"key":"e_1_2_13_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/bph.15542"},{"key":"e_1_2_13_22_1","doi-asserted-by":"publisher","DOI":"10.1007\/S00198\u2010021\u201006108\u2010W"},{"key":"e_1_2_13_23_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00774\u2010003\u20100459\u2010x"},{"key":"e_1_2_13_24_1","doi-asserted-by":"publisher","DOI":"10.1136\/gut.48.4.571"},{"key":"e_1_2_13_25_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.13867"},{"key":"e_1_2_13_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/0009\u20109236(95)90245\u20107"},{"key":"e_1_2_13_27_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00198\u2010012\u20102175\u20107"},{"key":"e_1_2_13_28_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00198\u2010018\u20104759\u20103"},{"key":"e_1_2_13_29_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00198\u2010018\u201004821\u20107"}],"container-title":["Pharmacology Research &amp; Perspectives"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/prp2.957","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/prp2.957","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/prp2.957","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,8]],"date-time":"2026-03-08T09:08:07Z","timestamp":1772960887000},"score":1,"resource":{"primary":{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/10.1002\/prp2.957"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,5,8]]},"references-count":28,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2022,6]]}},"alternative-id":["10.1002\/prp2.957"],"URL":"https:\/\/doi.org\/10.1002\/prp2.957","archive":["Portico"],"relation":{},"ISSN":["2052-1707","2052-1707"],"issn-type":[{"value":"2052-1707","type":"print"},{"value":"2052-1707","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,5,8]]},"assertion":[{"value":"2021-09-30","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-04-02","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-05-08","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e00957"}}