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Objective : To examine whether concomitant oral administration of febuxostat, a xanthine dehydrogenase /xanthine oxidase inhibitor, and inosine augments ATP in human blood. Methods : We performed Stage 1, Stage 2 and Stage 3 studies. In Stage 1 study, one adult healthy male was administered febuxostat 40 mg /day and inosine 1 g /day for 14 days to examine the safety of the combined therapy. In Stage 2, 21 healthy male adults were allocated to groups A-G, each with 3 subjects, and were treated with febuxostat alone, inosine alone or both for 14 days. In Stage 3, febuxostat 40 mg / day and inosine 1 g /day were administered to 5 healthy adult males for 14 days. Purine compounds in blood were compared between before and after the treatments in Stage 2 and Stage 3. Results : Combined use of febuxostat and inosine was relatively safe at doses of febuxostat 60 mg /day and inosine 3 g /day or less in a 2 week continuous treatment. Serum uric acid levels were markedly decreased by administration of febuxostat alone, and increased by the administration of inosine alone, but milder decreases were seen in combination therapy compared with febuxostat alone. In Stage 2, concomitant treatment with febuxostat 40 mg /day and inosine 1-2 g /day increased blood hypoxanthine and ATP, no increase occurred with inosine alone, and febuxostat alone slightly increased those values at the higher dose (60 mg /day). Increase in ATP in blood was confirmed by the results of Stage 3 where concomitant use of febuxostat 40 mg /day and inosine 1 g /day increased ATP by 13.8% (P = 0.031). Conclusions : Concomitant oral administration of febuxostat 40 mg /day and inosine 1-2 g /day was shown to safely increase blood ATP. Since cellular ATP deficiency may be involved in various disorders, the present method may be useful for the treatment of those disorders. Background ATP (adenosine triphosphate) (hereinafter sometimes referred to simply as ATP) is the most important compound for storing energy in living organisms and supplying it when needed, and it is considered that ATP reduction is related to the pathology of various diseases. For example, as a cause of hereditary hemolytic anemia, reduction of ATP in erythrocytes is Naoyuki Kamatani1) Masahiro Hashimoto1) Kuniko Sakurai1) Kaoru Gokita1) Junko Yoshihara1) Minoru Sekine1) Masa-aki Mochii1) Tomoko Fukuuchi2) Noriko Yamaoka2) Kiyoko Kaneko2) Clinical studies on changes in purine compounds in blood and urine by the simultaneous administration of febuxostat and inosine, or by single administration of each 受付:2017年5月13日,受理:2017年7月13日 1)Tsukuba International Clinical Pharmacology Clinic 2)Laboratory of Biomedical and Analytical Sciences, Faculty of Pharma-Science, Teikyo University

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&lt;b&gt;Clinical studies on changes in purine compounds in blood and urine by the simultaneous administration of febuxostat and inosine, or by single administration of each&lt;/b&gt;