{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T13:18:48Z","timestamp":1787663928815,"version":"build-2736575974"},"reference-count":19,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T00:00:00Z","timestamp":1785715200000},"content-version":"vor","delay-in-days":2,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Desmopressin is first\u2010line therapy for central diabetes insipidus, also known as arginine vasopressin deficiency, but presents dosing challenges due to its narrow therapeutic index. This open\u2010label, randomized, three\u2010way crossover study evaluated the bioequivalence of a new desmopressin acetate oral solution (50 mcg\/mL) compared to desmopressin acetate tablets (200 mcg) in 75 healthy adults. In a balanced, three\u2010sequence, three\u2010period design with 14\u2010day washout periods, participants received a single 600\u2010mcg dose of test product and reference product under fasted conditions. Plasma desmopressin concentrations were measured using a validated liquid chromatography\u2010electrospray ionization tandem mass spectrometry method, and primary pharmacokinetic parameters (maximum plasma concentration [C\n                    <jats:sub>max<\/jats:sub>\n                    ], area under the plasma concentration\u2013time curve from time 0 to the last measurable concentration [AUC\n                    <jats:sub>0\u2013t<\/jats:sub>\n                    ], AUC from time 0 extrapolated to infinity [AUC\n                    <jats:sub>0\u2013\u221e<\/jats:sub>\n                    ]) were derived from resulting concentration\u2013time profiles. Bioequivalence was assessed using analysis of variance on log\u2010transformed parameters, with 90% confidence intervals (CIs) for geometric mean ratios 80%\u2013125%. Results demonstrated bioequivalence between formulations, with geometric mean ratios of 101.9% (93.9%\u2013110.5%) for C\n                    <jats:sub>max<\/jats:sub>\n                    , 103.7% (94.8%\u2013113.5%) for AUC\n                    <jats:sub>0\u2013t<\/jats:sub>\n                    , and 103.7% (94.9%\u2013113.3%) for AUC\n                    <jats:sub>0\u2013\u221e<\/jats:sub>\n                    . Both formulations exhibited similar pharmacokinetic profiles with 1.0 h median time to maximum concentration, \u223c3.6 h mean elimination half\u2010life, and 30%\u201333% intrasubject variability. Five adverse events were reported by five participants (6.7%), including two cases of hyponatremia (reference group) and one case of vomiting (test group); all were mild to moderate and resolved completely. This study establishes bioequivalence between desmopressin acetate oral solution and tablets, supporting regulatory approval of the oral solution formulation.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.70086","type":"journal-article","created":{"date-parts":[[2026,8,4]],"date-time":"2026-08-04T06:46:38Z","timestamp":1785825998000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Open\u2010Label, Balanced, Randomized, Single\u2010Dose, Three\u2010Treatment, Three\u2010Sequence, Three\u2010Period, Three\u2010Way Crossover Oral Bioequivalence Study of Desmopressin Acetate Oral Solution"],"prefix":"10.1002","volume":"15","author":[{"given":"Adam","family":"Christensen","sequence":"first","affiliation":[{"name":"Eton Pharmaceuticals  Deer Park IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Axay","family":"Parth","sequence":"additional","affiliation":[{"name":"Veeda Clinical Research, Mehsana  Panchot India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mansi","family":"Kotak","sequence":"additional","affiliation":[{"name":"Veeda Clinical Research  Ahmedabad Gujarat India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danka","family":"Radosavjevic","sequence":"additional","affiliation":[{"name":"Eton Pharmaceuticals  Deer Park IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine Gorman","family":"Moore","sequence":"additional","affiliation":[{"name":"Eton Pharmaceuticals  Deer Park IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Byung\u2010Woun","family":"Seo","sequence":"additional","affiliation":[{"name":"Eton Pharmaceuticals  Deer Park IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,3]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.3389\/fendo.2024.1479764"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1530\/EJE-22-0751"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms23063068"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.lpm.2021.104093"},{"issue":"1","key":"e_1_2_10_6_1","article-title":"Diabetes insipidus: a pragmatic approach to management","volume":"13","author":"Priya G","year":"2021","journal-title":"Cureus"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1210\/clinem\/dgac381"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1210\/clinem\/dgab930"},{"key":"e_1_2_10_9_1","volume-title":"Prescribing information","author":"Desmopressin acetate tablets","year":"2019"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.beem.2020.101385"},{"key":"e_1_2_10_11_1","unstructured":"Desmopressin acetate injection.Prescribing information.UBI Pharma Inc;2022. 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