{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T05:33:59Z","timestamp":1789450439638,"version":"build-2803163510"},"reference-count":8,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2019,1,28]],"date-time":"2019-01-28T00:00:00Z","timestamp":1548633600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100015661","name":"UCB Pharma","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100015661","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bpspubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacology Res & Perspec"],"published-print":{"date-parts":[[2019,2]]},"abstract":"Abstract<\/jats:title>In this phase I, single\u2010center, open\u2010label study of ten heathy adults (18\u201045\u00a0years; NCT<\/jats:styled-content>02647697), the PK<\/jats:styled-content>, safety, and tolerability profile of radiprodil oral suspension in healthy adults were assessed, as well as two PK<\/jats:styled-content> microsampling techniques. All participants received a single 30\u00a0mg radiprodil dose (12\u00a0mL<\/jats:styled-content> oral suspension). Blood was collected at various time points using conventional venous sampling (intravenous catheter or venepuncture), and Mitra\u2122 and Aqua\u2010Cap\u2122 Drummond microsampling (finger\u2010prick and blood taken from venous blood sample tubes). Geometric mean radiprodil plasma concentrations from conventional venous samples were above the lower limit of quantification up to 48\u00a0hours after administration of a single oral dose of radiprodil. Geometric mean AUC<\/jats:styled-content>inf<\/jats:sub> and C<\/jats:italic>max<\/jats:sub> were 2042\u00a0h ng mL<\/jats:styled-content>\u22121<\/jats:sup> and 89.4\u00a0ng mL<\/jats:styled-content>\u22121<\/jats:sup>, respectively. Geometric mean t<\/jats:italic>&frac12;<\/jats:sub> was 15.8\u00a0hour; median t<\/jats:italic>max<\/jats:sub> was 4\u00a0hour (range: 3\u20106\u00a0hour). Radiprodil exposure variables for Aqua\u2010Cap\u2122 Drummond sampling were similar to the conventional venous\u2010derived data. Conversely, radiprodil exposure variables were lower with Mitra\u2122 sampling compared with conventional venous sampling. The geometric mean ratio (90% confidence interval) for C<\/jats:italic>max<\/jats:sub> of conventional venous versus Mitra\u2122 and Aqua\u2010Cap\u2122 Drummond sampling (finger\u2010prick blood) was 0.89 (0.85, 0.94) and 1.03 (0.97,1.08), respectively, and therefore within the conventional bioequivalence range (0.80\u20101.25). Radiprodil oral suspension had an acceptable safety, tolerability, and palatability profile. The PK<\/jats:styled-content> profile of radiprodil oral suspension was established in healthy adults, and was comparable when analyzed using conventional versus microsampling techniques. These results will support future radiprodil paediatric studies.<\/jats:p>","DOI":"10.1002\/prp2.459","type":"journal-article","created":{"date-parts":[[2019,1,29]],"date-time":"2019-01-29T04:18:19Z","timestamp":1548735499000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":23,"title":["A pharmacokinetic study of radiprodil oral suspension in healthy adults comparing conventional venous blood sampling with two microsampling techniques"],"prefix":"10.1002","volume":"7","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6090-8270","authenticated-orcid":false,"given":"David","family":"Sciberras","sequence":"first","affiliation":[{"name":"UCB Biopharma SPRL Braine l'Alleud Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Otoul","sequence":"additional","affiliation":[{"name":"UCB Biopharma SPRL Braine l'Alleud Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fran\u00e7oise","family":"Lurquin","sequence":"additional","affiliation":[{"name":"UCB Biopharma SPRL Braine l'Alleud Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Smeraglia","sequence":"additional","affiliation":[{"name":"UCB Biopharma SPRL Braine l'Alleud Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aur\u00e9lia","family":"Lappert","sequence":"additional","affiliation":[{"name":"UCB Biopharma SPRL Braine l'Alleud Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven","family":"De Bruyn","sequence":"additional","affiliation":[{"name":"UCB Biopharma SPRL Braine l'Alleud Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Jaap van Lier","sequence":"additional","affiliation":[{"name":"PRA Health Sciences \u2013 Early Development Services (PRA\u2010EDS) Groningen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,1,28]]},"reference":[{"key":"e_1_2_7_2_1","first-page":"CD001770","article-title":"Treatment of infantile spasms","author":"Hancock EC","year":"2013","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1021\/ac5022562"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.4155\/bio.13.58"},{"key":"e_1_2_7_5_1","volume-title":"Guidance for Industry","author":"FDA","year":"2013"},{"key":"e_1_2_7_6_1","unstructured":"American Academy of Pediatrics.Periodic survey #44 patient compliance with prescription regimens.2000. Available athttps:\/\/www.aap.org\/en-us\/professional-resources\/Research\/Pages\/PS44_Executive_Summary_PatientCompliancewithPrescriptionRegimens.aspx accessed on 02 February 2018."},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.2165\/00148581-200709050-00001"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.addr.2014.02.012"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2648.2012.06050.x"}],"container-title":["Pharmacology Research & Perspectives"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fprp2.459","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/prp2.459","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/prp2.459","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/prp2.459","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,10]],"date-time":"2023-09-10T18:13:17Z","timestamp":1694369597000},"score":1,"resource":{"primary":{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/10.1002\/prp2.459"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,1,28]]},"references-count":8,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2019,2]]}},"alternative-id":["10.1002\/prp2.459"],"URL":"https:\/\/doi.org\/10.1002\/prp2.459","archive":["Portico"],"relation":{},"ISSN":["2052-1707","2052-1707"],"issn-type":[{"value":"2052-1707","type":"print"},{"value":"2052-1707","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,1,28]]},"assertion":[{"value":"2018-05-17","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-11-27","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-01-28","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e00459"}}