{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T20:11:05Z","timestamp":1788379865328,"version":"build-2803163510"},"reference-count":12,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2023,11,23]],"date-time":"2023-11-23T00:00:00Z","timestamp":1700697600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2024,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The bioequivalence (BE) of orally administered capsules versus film tablets containing 20\u00a0 and 10\u00a0mg of rivaroxaban was assessed in 2 single\u2010dose, open\u2010label, randomized 2\u2010way crossover trials with a washout period of at least 1 week. The study for the 10\u00a0mg strength was conducted under fasting conditions (n = 68) and the study for the 20\u00a0mg strength under fed conditions (n = 52). Blood samples were collected over a 36\u2010hour period and concentrations were assayed using a liquid chromatography tandem mass spectrometry method. Pharmacokinetic (PK) evaluation was performed with the program Phoenix WinNonlin, for non\u2010compartmental assessment of data.<\/jats:p><jats:p>After administration of 10\u00a0mg rivaroxaban under fasting conditions, mean Area Under the time \u2010 concentration Curve until the last blood sampling point (AUC<jats:sub>t<\/jats:sub>), Area Under the time \u2010 concentration Curve until infinity (AUC<jats:sub>\u221e<\/jats:sub>), and maximum plasma concentration (C<jats:sub>max<\/jats:sub>) were comparable (972\u00a0ng\/mL*h, 1048\u00a0ng\/mL*h, and 111\u00a0ng\/mL, respectively, for the test and 1013\u00a0ng\/mL*h, 1070\u00a0ng\/mL*h and 130\u00a0ng\/mL, respectively, for the reference formulation). Mean AUC<jats:sub>t<\/jats:sub>, AUC<jats:sub>\u221e<\/jats:sub>, and C<jats:sub>max<\/jats:sub> were also comparable under fed conditions after administration of 20\u00a0mg rivaroxaban (2145\u00a0ng\/mL*h, 2198\u00a0ng\/mL*h and 275\u00a0ng\/mL, respectively, for the test and 1856\u00a0ng\/mL*h, 1916\u00a0ng\/mL*h and 240\u00a0ng\/mL, respectively, for the reference formulation). The 90% confidence intervals for all PK parameters were within the acceptance range of 80%\u2010125%, suggesting BE between the generic product and the innovator product in healthy Caucasian male subjects. A clinically relevant difference in the tolerability and safety of the treatments was not detected. Study results indicated that the capsule formulations were bioequivalent with the film tablet formulations.<\/jats:p>","DOI":"10.1002\/cpdd.1342","type":"journal-article","created":{"date-parts":[[2023,11,24]],"date-time":"2023-11-24T07:21:27Z","timestamp":1700810487000},"page":"281-287","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Bioequivalence Study of Capsules versus Film Tablets Containing Rivaroxaban in Healthy Caucasian Subjects under Fasting and Fed Conditions"],"prefix":"10.1002","volume":"13","author":[{"given":"G\u00f6k\u00e7e","family":"S\u00f6zer","sequence":"first","affiliation":[{"name":"Sanovel \u0130la\u00e7 Sanayi ve Ticaret A.S.  Istanbul T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmet","family":"Inal","sequence":"additional","affiliation":[{"name":"Hakan \u00c7etinsaya Good Clinical Practise Centre (IKUM) Erciyes University and Department of Medical Pharmacology Faculty of Medicine Erciyes University  Kayseri T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zafer","family":"Sezer","sequence":"additional","affiliation":[{"name":"Hakan \u00c7etinsaya Good Clinical Practise Centre (IKUM) Erciyes University and Department of Medical Pharmacology Faculty of Medicine Erciyes University  Kayseri T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wolfgang","family":"Martin","sequence":"additional","affiliation":[{"name":"Pharmakin Consulting Services UG  Neu\u2010Ulm Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ewald","family":"Ottmann","sequence":"additional","affiliation":[{"name":"Pharmakin Consulting Services UG  Neu\u2010Ulm Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Reinsch","sequence":"additional","affiliation":[{"name":"Analytisches Zentrum Biopharm GmbH  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Selma Alime","family":"Koru","sequence":"additional","affiliation":[{"name":"IDEAL Biyolojik \u00dcr\u00fcnler ve \u0130la\u00e7 Dan\u0131\u015fmanl\u0131k E\u011fitim Ltd. \u015eti.  Ankara T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,11,23]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1538-7836.2007.02473.x"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra0801082"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-019-02639-8"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1161\/ATVBAHA.110.202978"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270007302952"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1538-7836.2005.01166.x"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270006286904"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.5414\/CP201812"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-013-0100-7"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.958"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.742"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.2009.03390.x"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1342","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,3,1]],"date-time":"2024-03-01T08:06:18Z","timestamp":1709280378000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.1342"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,11,23]]},"references-count":12,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2024,3]]}},"alternative-id":["10.1002\/cpdd.1342"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.1342","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,11,23]]},"assertion":[{"value":"2023-08-10","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-10-22","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-11-23","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}