{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,27]],"date-time":"2026-06-27T01:17:12Z","timestamp":1782523032048,"version":"3.54.5"},"reference-count":17,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2015,12,14]],"date-time":"2015-12-14T00:00:00Z","timestamp":1450051200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100005205","name":"Janssen Research & Development, LLC","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100005205","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2016,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The objective of these 2 phase 1, open\u2010label, 2\u2010treatment, single\u2010sequence studies was to evaluate the effect of repeated oral doses of divalproex sodium extended\u2010release (ER) on the pharmacokinetics (PK) of a single dose of paliperidone ER in healthy participants (study 1), and the effect of multiple doses of paliperidone ER on the steady\u2010state PK of valproic acid (VPA) in patients with psychiatric disorders (study 2), respectively. In study 1 healthy participants received, in a fixed sequential order, treatment A, paliperidone ER 12 mg (day 1); treatment B, VPA 1000 mg (2 \u00d7 500 mg divalproex sodium ER) once daily (days 5 to 18) and paliperidone ER 12 mg (day 15). In study 2 patients received treatment A, VPA (days 1\u20137); treatment B, VPA + paliperidone ER 12 mg (days 8\u201312). Divalproex sodium ER doses (study 2) were individualized such that systemic therapeutic VPA exposure from prior treatment was maintained on entry into the study. PK assessments were performed at prespecified time points (paliperidone days 1 and 15 [study 1]; VPA days 7 and 12 [study 2]). The oral bioavailability of paliperidone was increased by an estimated 51% (C<jats:sub>max<\/jats:sub>) and 51%\u201352% (AUCs) when coadministered with divalproex sodium ER. No effect on the steady\u2010state plasma concentration of VPA was observed following repeated coadministration with paliperidone ER: the 90%CI around the VPA exposure ratios for the 2 treatments was within the 80%\u2013125% bioequivalence criteria for C<jats:sub>max,ss<\/jats:sub> and AUC<jats:sub>\u03c4<\/jats:sub>. Both VPA and paliperidone ER were well tolerated, and no new safety concerns were identified.<\/jats:p>","DOI":"10.1002\/jcph.648","type":"journal-article","created":{"date-parts":[[2015,9,28]],"date-time":"2015-09-28T09:44:40Z","timestamp":1443433480000},"page":"683-692","source":"Crossref","is-referenced-by-count":15,"title":["Drug\u2010Drug Interaction Studies of Paliperidone and Divalproex Sodium Extended\u2010Release Tablets in Healthy Participants and Patients with Psychiatric Disorders"],"prefix":"10.1002","volume":"56","author":[{"given":"Bart","family":"Remmerie","sequence":"first","affiliation":[{"name":"Janssen Research &amp; Development Division of Janssen Pharmaceutica NV  Beerse Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jay","family":"Ariyawansa","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development Division of Janssen Pharmaceutica NV  Beerse Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"De Meulder","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development Division of Janssen Pharmaceutica NV  Beerse Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danielle","family":"Coppola","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development LLC  Raritan NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joris","family":"Berwaerts","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development LLC  Raritan NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2015,12,14]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/oxfordjournals.schbul.a006928"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0030-1249097"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.2147\/NDT.S12612"},{"issue":"5","key":"e_1_2_12_5_1","first-page":"9","article-title":"Monotherapy versus combined treatment with second\u2010generation antipsychotics in bipolar disorder","volume":"69","author":"Ketter TA","year":"2008","journal-title":"J Clin Psychiatry"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.107.018275"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.npp.1301181"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.0306-5251.2001.01474.x"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.bjp.0706830"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1177\/0269881109106914"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1097\/00007691-200008000-00019"},{"key":"e_1_2_12_12_1","unstructured":"RossenuS CletonA BoomS et\u00a0al.Comparison of the pharmacokinetics of an oral immediate\u2010release and extended\u2010release formulation of paliperidone in healthy subjects. Poster presented at: the Annual Meeting and Exposition of the American Association of Pharmaceutical Sciences (AAPS) San Antonio TX: October 29\u2010November 2 2006."},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eplepsyres.2006.11.005"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jad.2010.09.011"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-008-0579-2"},{"issue":"10","key":"e_1_2_12_16_1","first-page":"1433","article-title":"Influence of physical activity on gastric emptying of liquids in normal human subjects","volume":"86","author":"Marzio L","year":"1991","journal-title":"Am J Gastroenterol"},{"key":"e_1_2_12_17_1","volume-title":"Physiological Pharmaceutics, Barriers to Drug Absorption","author":"Washington N"},{"key":"e_1_2_12_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.1990.tb05449.x"}],"container-title":["The Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fjcph.648","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcph.648","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,4]],"date-time":"2023-10-04T07:53:57Z","timestamp":1696406037000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/jcph.648"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,12,14]]},"references-count":17,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2016,6]]}},"alternative-id":["10.1002\/jcph.648"],"URL":"https:\/\/doi.org\/10.1002\/jcph.648","archive":["Portico"],"relation":{},"ISSN":["0091-2700","1552-4604"],"issn-type":[{"value":"0091-2700","type":"print"},{"value":"1552-4604","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,12,14]]}}}