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We conducted two open\u2010label, randomized, single\u2010dose, four\u2010period, two\u2010sequence, full\u2010replicate, crossover trials to characterize the pharmacokinetics and relative bioavailability of the novel 6\u2010MP mini\u2010tablet (N) compared to the reference 6\u2010MP tablet (R) under both fasted and fed conditions. The 6\u2010MP plasma concentrations were measured using ultra performance liquid chromatography \u2010 tandem mass\u00a0spectrometry (UPLC\u2010MS\/MS). The C\n                    <jats:sub>max<\/jats:sub>\n                    , AUC\n                    <jats:sub>0\u2013t<\/jats:sub>\n                    , and AUC\n                    <jats:sub>0\u2013inf<\/jats:sub>\n                    were used to evaluate the relative bioavailability. The results showed that the 6\u2010MP mini\u2010tablet was bioequivalent to the reference formulation under fasting condition. Under the fasted condition, the geometric least\u2010squares mean ratios (GLSMR) (90% CI) of C\n                    <jats:sub>max<\/jats:sub>\n                    , AUC\n                    <jats:sub>0\u2013t<\/jats:sub>\n                    , and AUC\n                    <jats:sub>0\u2013inf<\/jats:sub>\n                    of N over R were 91.71% (81.31%\u2013103.44%), 97.53% (92.57%\u2013102.76%), and 97.91% (93.17%\u2013102.90%), respectively. The mean CL\/F (238.4 vs 219.3 L\/h), the mean V\n                    <jats:sub>d<\/jats:sub>\n                    \/F (523.4 vs 451.8 L), the median T\n                    <jats:sub>max<\/jats:sub>\n                    (1.50 vs 1.25 h), and the mean t\n                    <jats:sub>1\/2<\/jats:sub>\n                    (1.55 vs 1.44 h) of N and R showed similarity. Under fed condition, the GLSMR (90% CI) of C\n                    <jats:sub>max<\/jats:sub>\n                    , AUC\n                    <jats:sub>0\u2013t<\/jats:sub>\n                    , and AUC\n                    <jats:sub>0\u2013inf<\/jats:sub>\n                    of N over R were 68.16% (59.62%\u201377.93%), 86.22% (81.37%\u201391.37%), and 86.59% (81.88%\u201391.57%), respectively. Furthermore, a high\u2010fat diet increased both CL\/F and V\n                    <jats:sub>d<\/jats:sub>\n                    \/F of 6\u2010MP and decreased exposure of 6\u2010MP, with all changes exceeding two\u2010fold. Both products exhibited a favorable safety profile without any SAE being observed. These results supported the marketing of 6\u2010MP mini\u2010tablets.\n                  <\/jats:p>","DOI":"10.1002\/jcph.70178","type":"journal-article","created":{"date-parts":[[2026,4,3]],"date-time":"2026-04-03T09:38:46Z","timestamp":1775209126000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["The Pharmacokinetics and Relative Bioavailability of a Mini\u2010Tablet of Mercaptopurine, a Novel Formulation for Use in Children with Acute Lymphoblastic Leukemia"],"prefix":"10.1002","volume":"66","author":[{"given":"Zhi","family":"Chen","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacy, Key Laboratory of Chemical Biology (Ministry of Education), School of Pharmaceutical Sciences, Cheeloo College of Medicine Shandong University  Jinan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuan\u2010Yuan","family":"Zheng","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, The First Affiliated Hospital of Shandong First Medical University &amp; Shandong Provincial Qianfoshan Hospital, Shandong Engineering and Technology Research Center for Pediatric Drug Development Shandong Medicine and Health Key Laboratory of Clinical Pharmacy  Jinan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qing\u2010Liang","family":"Liu","sequence":"additional","affiliation":[{"name":"China Resources Double\u2010Crane Pharmaceutical Co., Ltd.  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pan\u2010Pan","family":"Ye","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, Key Laboratory of Chemical Biology (Ministry of Education), School of Pharmaceutical Sciences, Cheeloo College of Medicine Shandong University  Jinan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xin\u2010Mei","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, The First Affiliated Hospital of Shandong First Medical University &amp; Shandong Provincial Qianfoshan Hospital, Shandong Engineering and Technology Research Center for Pediatric Drug Development Shandong Medicine and Health Key Laboratory of Clinical Pharmacy  Jinan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lin\u2010Lin","family":"Song","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, The First Affiliated Hospital of Shandong First Medical University &amp; Shandong Provincial Qianfoshan Hospital, Shandong Engineering and Technology Research Center for Pediatric Drug Development Shandong Medicine and Health Key Laboratory of Clinical Pharmacy  Jinan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ke\u2010Guang","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, The First Affiliated Hospital of Shandong First Medical University &amp; Shandong Provincial Qianfoshan Hospital, Shandong Engineering and Technology Research Center for Pediatric Drug Development Shandong Medicine and Health Key Laboratory of Clinical Pharmacy  Jinan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fu\u2010Rong","family":"Zhao","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, The First Affiliated Hospital of Shandong First Medical University &amp; Shandong Provincial Qianfoshan Hospital, Shandong Engineering and Technology Research Center for Pediatric Drug Development Shandong Medicine and Health Key Laboratory of Clinical Pharmacy  Jinan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jin\u2010Yi","family":"Shi","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, The First Affiliated Hospital of Shandong First Medical University &amp; Shandong Provincial Qianfoshan Hospital, Shandong Engineering and Technology Research Center for Pediatric Drug Development Shandong Medicine and Health Key Laboratory of Clinical Pharmacy  Jinan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ye\u2010Hui","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, The First Affiliated Hospital of Shandong First Medical University &amp; Shandong Provincial Qianfoshan Hospital, Shandong Engineering and Technology Research Center for Pediatric Drug Development Shandong Medicine and Health Key Laboratory of Clinical Pharmacy  Jinan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hai\u2010Yan","family":"Zhou","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, The First Affiliated Hospital of Shandong First Medical University &amp; Shandong Provincial Qianfoshan Hospital, Shandong Engineering and Technology Research Center for Pediatric Drug Development Shandong Medicine and Health Key Laboratory of Clinical Pharmacy  Jinan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"van den Anker","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, Key Laboratory of Chemical Biology (Ministry of Education), School of Pharmaceutical Sciences, Cheeloo College of Medicine Shandong University  Jinan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan","family":"Yang","sequence":"additional","affiliation":[{"name":"China Resources Double\u2010Crane Pharmaceutical Co., Ltd.  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