{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T02:19:27Z","timestamp":1787624367684,"version":"build-2736575974"},"reference-count":18,"publisher":"Springer Science and Business Media LLC","issue":"11","license":[{"start":{"date-parts":[[2026,5,25]],"date-time":"2026-05-25T00:00:00Z","timestamp":1779667200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2026,5,25]],"date-time":"2026-05-25T00:00:00Z","timestamp":1779667200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Naunyn-Schmiedeberg's Arch Pharmacol"],"published-print":{"date-parts":[[2026,8]]},"DOI":"10.1007\/s00210-026-05498-0","type":"journal-article","created":{"date-parts":[[2026,5,25]],"date-time":"2026-05-25T05:55:58Z","timestamp":1779688558000},"page":"17561-17569","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A randomized, open-label, three-period, cross-over, single intravenous or intramuscular dose, pharmacokinetics and bioequivalence study of vitamin K1 in healthy adults"],"prefix":"10.1007","volume":"399","author":[{"given":"Yan","family":"Li","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lu","family":"Qi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yinjuan","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenjing","family":"Zhong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xinghe","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,5,25]]},"reference":[{"issue":"1","key":"5498_CR1","doi-asserted-by":"publisher","first-page":"118","DOI":"10.1160\/TH09-12-0822","volume":"104","author":"MA Crowther","year":"2010","unstructured":"Crowther MA, Garcia D, Ageno W et al (2010) Oral vitamin K effectively treats international normalised ratio (INR) values in excess of 10. Results of a prospective cohort study. Thromb Haemost 104(1):118\u2013121. https:\/\/doi.org\/10.1160\/TH09-12-0822","journal-title":"Thromb Haemost"},{"issue":"1","key":"5498_CR2","doi-asserted-by":"publisher","first-page":"605","DOI":"10.1182\/asheducation-2016.1.605","volume":"2016","author":"S Eichinger","year":"2016","unstructured":"Eichinger S (2016) Reversing vitamin K antagonists: making the old new again. Hematology Am Soc Hematol Educ Program 2016(1):605\u2013611. https:\/\/doi.org\/10.1182\/asheducation-2016.1.605","journal-title":"Hematology Am Soc Hematol Educ Program"},{"issue":"2","key":"5498_CR3","doi-asserted-by":"publisher","first-page":"223","DOI":"10.1079\/bjn19960027","volume":"76","author":"BL Gijsbers","year":"1996","unstructured":"Gijsbers BL, Jie KS, Vermeer C (1996) Effect of food composition on vitamin K absorption in human volunteers. Br J Nutr 76(2):223\u2013229. https:\/\/doi.org\/10.1079\/bjn19960027","journal-title":"Br J Nutr"},{"key":"5498_CR4","unstructured":"Guidelines for bioequivalence studies of generic chemical drugs using pharmacokinetic parameters as endpoint evaluation indicators. Available online at: https:\/\/www.cde.org.cn\/zdyz\/domesticinfopage?zdyzIdCODE=1e218f70d9b7c99c2663de9f6655bc5b"},{"key":"5498_CR5","doi-asserted-by":"publisher","first-page":"98","DOI":"10.1016\/j.jpeds.2022.10.031","volume":"255","author":"CR Hunnali","year":"2023","unstructured":"Hunnali CR, Devi U, Kitchanan S, Sethuraman G (2023) Three different regimens for vitamin K birth prophylaxis in infants born preterm: a randomized clinical trial. J Pediatr 255:98\u2013104. https:\/\/doi.org\/10.1016\/j.jpeds.2022.10.031","journal-title":"J Pediatr"},{"issue":"6","key":"5498_CR6","doi-asserted-by":"publisher","first-page":"879","DOI":"10.1345\/aph.1Q769","volume":"46","author":"HJ Ipema","year":"2012","unstructured":"Ipema HJ (2012) Use of oral vitamin K for prevention of late vitamin K deficiency bleeding in neonates when injectable vitamin K is not available. Ann Pharmacother 46(6):879\u2013883. https:\/\/doi.org\/10.1345\/aph.1Q769","journal-title":"Ann Pharmacother"},{"issue":"8","key":"5498_CR7","doi-asserted-by":"publisher","first-page":"1195","DOI":"10.1017\/S0007114509371688","volume":"102","author":"KS Jones","year":"2009","unstructured":"Jones KS, Bluck LJ, Wang LY, Stephen AM, Prynne CJ, Coward WA (2009) The effect of different meals on the absorption of stable isotope-labelled phylloquinone. Br J Nutr 102(8):1195\u20131202. https:\/\/doi.org\/10.1017\/S0007114509371688","journal-title":"Br J Nutr"},{"issue":"20","key":"5498_CR8","doi-asserted-by":"publisher","first-page":"2469","DOI":"10.1001\/archinte.163.20.2469","volume":"163","author":"A Lubetsky","year":"2003","unstructured":"Lubetsky A, Yonath H, Olchovsky D, Loebstein R, Halkin H, Ezra D (2003) Comparison of oral vs intravenous phytonadione (vitamin K1) in patients with excessive anticoagulation: a prospective randomized controlled study. Arch Intern Med 163(20):2469\u20132473. https:\/\/doi.org\/10.1001\/archinte.163.20.2469","journal-title":"Arch Intern Med"},{"issue":"3","key":"5498_CR9","doi-asserted-by":"publisher","first-page":"467","DOI":"10.1007\/s00228-012-1362-y","volume":"69","author":"M Marinova","year":"2013","unstructured":"Marinova M, L\u00fctjohann D, Breuer O et al (2013) VKORC1-dependent pharmacokinetics of intravenous and oral phylloquinone (vitamin K1) mixed micelles formulation. Eur J Clin Pharmacol 69(3):467\u2013475. https:\/\/doi.org\/10.1007\/s00228-012-1362-y","journal-title":"Eur J Clin Pharmacol"},{"issue":"6","key":"5498_CR10","doi-asserted-by":"publisher","first-page":"356","DOI":"10.1891\/0730-0832\/11-T-630","volume":"39","author":"C McPherson","year":"2020","unstructured":"McPherson C (2020) Vitamin K deficiency bleeding: an ounce of prevention. Neonatal Netw 39(6):356\u2013362. https:\/\/doi.org\/10.1891\/0730-0832\/11-T-630","journal-title":"Neonatal Netw"},{"issue":"3","key":"5498_CR11","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0090199","volume":"9","author":"YN Mi","year":"2014","unstructured":"Mi YN, Ping NN, Xiao X, Zhu YB, Liu J, Cao YX (2014) The severe adverse reaction to vitamin K1 injection is anaphylactoid reaction but not anaphylaxis. PLoS ONE 9(3):e90199. https:\/\/doi.org\/10.1371\/journal.pone.0090199. (Published 2014 Mar 4)","journal-title":"PLoS ONE"},{"issue":"1","key":"5498_CR12","doi-asserted-by":"publisher","first-page":"123","DOI":"10.1097\/MPG.0000000000001232","volume":"63","author":"WA Mihatsch","year":"2016","unstructured":"Mihatsch WA, Braegger C, Bronsky J et al (2016) Prevention of Vitamin K deficiency bleeding in newborn infants: A position paper by the ESPGHAN Committee on Nutrition. J Pediatr Gastroenterol Nutr 63(1):123\u2013129. https:\/\/doi.org\/10.1097\/MPG.0000000000001232","journal-title":"J Pediatr Gastroenterol Nutr"},{"issue":"4","key":"5498_CR13","doi-asserted-by":"publisher","first-page":"677","DOI":"10.1093\/nutrit\/nuab061","volume":"80","author":"P Mlad\u011bnka","year":"2022","unstructured":"Mlad\u011bnka P, Mac\u00e1kov\u00e1 K, Kujovsk\u00e1 Kr\u010dmov\u00e1 L et al (2022) Vitamin K - sources, physiological role, kinetics, deficiency, detection, therapeutic use, and toxicity. Nutr Rev 80(4):677\u2013698. https:\/\/doi.org\/10.1093\/nutrit\/nuab061","journal-title":"Nutr Rev"},{"issue":"2","key":"5498_CR14","doi-asserted-by":"publisher","first-page":"116","DOI":"10.1007\/s13312-025-3374-6","volume":"62","author":"AS Natarajan","year":"2025","unstructured":"Natarajan AS, Delhikumar CG, Senthil Kumar GP, Mondal N, Sasirekha R (2025) One milligram versus two milligram intramuscular vitamin K to prevent late-onset hemorrhagic disease in young infants: a randomized controlled trial. Indian Pediatr 62(2):116\u2013120. https:\/\/doi.org\/10.1007\/s13312-025-3374-6","journal-title":"Indian Pediatr"},{"key":"5498_CR15","unstructured":"New Zealand data sheet of Konakion\u00ae MM, 10mg\/mL solution for injection. Available online at: https:\/\/www.medsafe.govt.nz\/profs\/datasheet\/k\/Konakiontabinjoralsoln.pdf"},{"issue":"4","key":"5498_CR16","doi-asserted-by":"publisher","DOI":"10.1111\/eci.14141","volume":"54","author":"S Perrone","year":"2024","unstructured":"Perrone S, De Bernardo G, Lembo C et al (2024) Vitamin K insufficiency and the prophylaxis strategy in term healthy infants: a multicentre study. Eur J Clin Invest 54(4):e14141. https:\/\/doi.org\/10.1111\/eci.14141","journal-title":"Eur J Clin Invest"},{"issue":"6","key":"5498_CR17","doi-asserted-by":"publisher","first-page":"517","DOI":"10.1046\/j.1365-2125.1996.03847.x","volume":"41","author":"JR Soedirman","year":"1996","unstructured":"Soedirman JR, De Bruijn EA, Maes RA, Hanck A, Gr\u00fcter J (1996) Pharmacokinetics and tolerance of intravenous and intramuscular phylloquinone (vitamin K1) mixed micelles formulation. Br J Clin Pharmacol 41(6):517\u2013523. https:\/\/doi.org\/10.1046\/j.1365-2125.1996.03847.x","journal-title":"Br J Clin Pharmacol"},{"issue":"9","key":"5498_CR18","doi-asserted-by":"publisher","first-page":"1333","DOI":"10.1007\/s00228-021-03127-8","volume":"77","author":"H Zhang","year":"2021","unstructured":"Zhang H, Li M, Ao XL, Dong YJ, Dong L (2021) Randomized, placebo-controlled trial of orally administered vitamin K1 for warfarin-associated coagulopathy in Chinese patients with mechanical heart valves. Eur J Clin Pharmacol 77(9):1333\u20131339. https:\/\/doi.org\/10.1007\/s00228-021-03127-8","journal-title":"Eur J Clin Pharmacol"}],"container-title":["Naunyn-Schmiedeberg's Archives of Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00210-026-05498-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00210-026-05498-0","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00210-026-05498-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T01:24:05Z","timestamp":1787621045000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00210-026-05498-0"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,25]]},"references-count":18,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2026,8]]}},"alternative-id":["5498"],"URL":"https:\/\/doi.org\/10.1007\/s00210-026-05498-0","relation":{},"ISSN":["0028-1298","1432-1912"],"issn-type":[{"value":"0028-1298","type":"print"},{"value":"1432-1912","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,25]]},"assertion":[{"value":"15 October 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"21 May 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"25 May 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The study was performed in accordance with the consensus ethics principles derived from international ethics guidelines, including the Declaration of Helsinki, the International Council for Harmonization Guidelines for Good Clinical Practice (GCP), and all applicable laws, rules, and regulations. Approval for the study protocol and informed consent documentation was granted by the Ethics Committee of Beijing Shijitan Hospital, Capital Medical University (Approval Number: 2023(10)).","order":1,"name":"Ethics","label":"Ethical approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All participants provided written informed consent following comprehensive briefing on the study procedures prior to screening.","order":2,"name":"Ethics","label":"Consent to participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The study was registered on the Chinese Clinical Trial website (\n                      \n                      , number: CTR20230319, date: February6, 2023) and the Chinese Clinical Trial Registry, which is recognized by the WHO (\n                      \n                      , number: ChiCTR2400082941, date: December 17, 2024).","order":3,"name":"Ethics","label":"Clinical trial registration","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Wenjing Zhong is an employee of Hainan Brilliant Pharmaceutical Co., Ltd.. The authors report no other conflicts of interest in this work.","order":4,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Declarations"}}]}}