{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T17:38:57Z","timestamp":1791567537429,"version":"4.3.4"},"reference-count":23,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2018,12,21]],"date-time":"2018-12-21T00:00:00Z","timestamp":1545350400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","award":["OPP1063223T"],"award-info":[{"award-number":["OPP1063223T"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2019,1]]},"abstract":"<jats:p>Orally dispersible tablet (<jats:styled-content style=\"fixed-case\">ODT<\/jats:styled-content>) formulations of levo praziquantel (<jats:styled-content style=\"fixed-case\">L\u2010PZQ<\/jats:styled-content>) and racemic PZQ (rac\u2010PZQ) are being developed to treat schistosomiasis in preschool\u2010aged children. Two crossover studies (<jats:italic>N<\/jats:italic>\u00a0=\u00a032 and 36, respectively) assessed the relative bioavailability of these <jats:styled-content style=\"fixed-case\">ODT<\/jats:styled-content>s vs. Cysticide in adults. Bioavailability for L\u2010<jats:styled-content style=\"fixed-case\">PZQ<\/jats:styled-content> of <jats:styled-content style=\"fixed-case\">ODT<\/jats:styled-content> rac\u2010<jats:styled-content style=\"fixed-case\">PZQ<\/jats:styled-content> and Cysticide at 40\u00a0mg\/kg was comparable (L\u2010<jats:styled-content style=\"fixed-case\">PZQ<\/jats:styled-content> area under the concentration\u2010time curve from zero to infinity (<jats:styled-content style=\"fixed-case\">AUC<\/jats:styled-content><jats:sub>0\u2013\u221e<\/jats:sub>) test\/reference ratio (90% confidence interval (CI)): 96% (84\u2013111%)), whereas relative bioavailability of <jats:styled-content style=\"fixed-case\">ODT<\/jats:styled-content> L\u2010<jats:styled-content style=\"fixed-case\">PZQ<\/jats:styled-content> 20\u00a0mg\/kg was ~40% that of Cysticide 40\u00a0mg\/kg (test\/reference: 40% (35\u201346%)). <jats:styled-content style=\"fixed-case\">AUC<\/jats:styled-content><jats:sub>0\u2010\u221e<\/jats:sub> and peak plasma concentration (C<jats:sub>max<\/jats:sub>) were highly variable in both studies. For both <jats:styled-content style=\"fixed-case\">ODT<\/jats:styled-content>s, L\u2010<jats:styled-content style=\"fixed-case\">PZQ AUC<\/jats:styled-content><jats:sub>0\u2013\u221e<\/jats:sub> showed greater than dose\u2010proportional increase over the ranges tested and a significant food effect. Safety was comparable among formulations. The lower bioavailability of <jats:styled-content style=\"fixed-case\">ODT<\/jats:styled-content> L\u2010<jats:styled-content style=\"fixed-case\">PZQ<\/jats:styled-content>, as well as the high variability and nondose\u2010proportionality of pharmacokinetic (PK) parameters, highlighted the need for a dedicated pediatric dose\u2010finding study for the selection of the most appropriate formulation and dose (L\u2010<jats:styled-content style=\"fixed-case\">PZQ ODT<\/jats:styled-content> or rac\u2010<jats:styled-content style=\"fixed-case\">PZQ ODT<\/jats:styled-content>).<\/jats:p>","DOI":"10.1111\/cts.12601","type":"journal-article","created":{"date-parts":[[2018,12,7]],"date-time":"2018-12-07T17:32:39Z","timestamp":1544203959000},"page":"66-76","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":30,"title":["Relative Bioavailability of Orally Dispersible Tablet Formulations of Levo\u2010 and Racemic Praziquantel: Two Phase I Studies"],"prefix":"10.1111","volume":"12","author":[{"given":"Wilhelmina Maria","family":"Bagchus","sequence":"first","affiliation":[{"name":"Quantitative Pharmacology Merck Institute for Pharmacometrics (an affiliate of Merck KGaA, Darmstadt, Germany)  Lausanne Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deon","family":"Bezuidenhout","sequence":"additional","affiliation":[{"name":"Merck KGaA  Modderfontein South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eleanor","family":"Harrison\u2010Moench","sequence":"additional","affiliation":[{"name":"Quantitative Pharmacology Merck KGaA  Darmstadt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elly","family":"Kourany\u2010Lefoll","sequence":"additional","affiliation":[{"name":"Global Health Institute Ares Trading S.A.  Coinsins Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Wolna","sequence":"additional","affiliation":[{"name":"Global Biostatistics Merck KGaA  Darmstadt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oezkan","family":"Yalkinoglu","sequence":"additional","affiliation":[{"name":"Quantitative Pharmacology Merck KGaA  Darmstadt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,12,21]]},"reference":[{"key":"e_1_2_11_1_1","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v6.i1.12"},{"key":"e_1_2_11_2_1","unstructured":"World Health Organization [Internet].World Health Organization Geneva c2016. Fact Sheet No. 115: Schistosomiasis. [about 6 screens]. <http:\/\/www.who.int\/mediacentre\/factsheets\/fs115\/en\/index.html> (2016). 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