{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T20:49:40Z","timestamp":1790887780269,"version":"4.1.0"},"reference-count":17,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T00:00:00Z","timestamp":1761868800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T00:00:00Z","timestamp":1761868800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"funder":[{"name":"Major Projects of Hangzhou Health Science and Technology","award":["No. Z20220024"],"award-info":[{"award-number":["No. Z20220024"]}]},{"name":"The Zhejiang Province Leading Geese Plan","award":["2024C03099"],"award-info":[{"award-number":["2024C03099"]}]},{"name":"Key R&D Program of Hangzhou Science and Technology Bureau","award":["20241203A17"],"award-info":[{"award-number":["20241203A17"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drugs R D"],"published-print":{"date-parts":[[2025,12]]},"DOI":"10.1007\/s40268-025-00525-6","type":"journal-article","created":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T15:26:53Z","timestamp":1761924413000},"page":"321-331","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Bioequivalence Study of Bedaquiline and Sirturo\u00ae in Healthy Chinese Subjects Under Fasting and Postprandial Conditions: A Randomized, Open-Label, Single-Dose, Crossover Trial"],"prefix":"10.1007","volume":"25","author":[{"given":"Yixuan","family":"Li","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yi","family":"Wu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shufan","family":"Cai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiangxin","family":"Huang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lijun","family":"Ye","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lin","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yingying","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2121-7025","authenticated-orcid":false,"given":"Ying","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xuexia","family":"Tao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,10,31]]},"reference":[{"issue":"559","key":"525_CR1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cca.2024.119701","volume":"1","author":"DA Wulandari","year":"2024","unstructured":"Wulandari DA, Hartati YW, Ibrahim AU, Pitaloka DAE. Irkham. Multidrug-resistant tuberculosis. Clin Chim Acta. 2024;1(559):119701.","journal-title":"Clin Chim Acta"},{"issue":"14","key":"525_CR2","doi-asserted-by":"publisher","first-page":"1022090","DOI":"10.3389\/fphar.2023.1022090","volume":"27","author":"G Shao","year":"2023","unstructured":"Shao G, Bao Z, Davies Forsman L, Paues J, Werngren J, Niward K, et al. Population pharmacokinetics and model-based dosing evaluation of bedaquiline in multidrug-resistant tuberculosis patients. Front Pharmacol. 2023;27(14):1022090.","journal-title":"Front Pharmacol"},{"issue":"10","key":"525_CR3","doi-asserted-by":"publisher","first-page":"875","DOI":"10.1080\/14740338.2019.1648429","volume":"18","author":"K Cohen","year":"2019","unstructured":"Cohen K, Maartens G. A safety evaluation of bedaquiline for the treatment of multi-drug resistant tuberculosis. Expert Opin Drug Saf. 2019;18(10):875\u201382.","journal-title":"Expert Opin Drug Saf"},{"issue":"5707","key":"525_CR4","doi-asserted-by":"publisher","first-page":"223","DOI":"10.1126\/science.1106753","volume":"307","author":"K Andries","year":"2005","unstructured":"Andries K, Verhasselt P, Guillemont J, G\u00f6hlmann HW, Neefs JM, Winkler H, et al. A diarylquinoline drug active on the ATP synthase of Mycobacterium tuberculosis. Science. 2005;307(5707):223\u20137.","journal-title":"Science"},{"issue":"10","key":"525_CR5","doi-asserted-by":"publisher","DOI":"10.1128\/aac.00811-22","volume":"66","author":"J Zou","year":"2022","unstructured":"Zou J, Chen S, Rao W, Fu L, Zhang J, Liao Y, et al. Population pharmacokinetic modeling of bedaquiline among multidrug-resistant pulmonary tuberculosis patients from China. Antimicrob Agents Chemother. 2022;66(10):e0081122.","journal-title":"Antimicrob Agents Chemother"},{"key":"525_CR6","doi-asserted-by":"crossref","unstructured":"van Heeswijk RP, Dannemann B, Hoetelmans RM. Bedaquiline: a review of human pharmacokinetics and drug-drug interactions. J Antimicrob Chemother. 2014;69(9):2310-2318","DOI":"10.1093\/jac\/dku171"},{"issue":"3","key":"525_CR7","doi-asserted-by":"publisher","first-page":"347","DOI":"10.1007\/s00228-024-03788-1","volume":"81","author":"J Jin","year":"2025","unstructured":"Jin J, Cao J, Zhang R, Zheng L, Cai X, Li J. Population pharmacokinetics of bedaquiline: a systematic review. Eur J Clin Pharmacol. 2025;81(3):347\u201363.","journal-title":"Eur J Clin Pharmacol"},{"issue":"12","key":"525_CR8","doi-asserted-by":"publisher","DOI":"10.1016\/S2666-5247(24)00149-6","volume":"5","author":"ES Shaw","year":"2024","unstructured":"Shaw ES, Stoker NG, Potter JL, Claassen H, Leslie A, Tweed CD, et al. Bedaquiline: what might the future hold? Lancet Microbe. 2024;5(12):100909.","journal-title":"Lancet Microbe"},{"issue":"2","key":"525_CR9","doi-asserted-by":"publisher","first-page":"463","DOI":"10.1111\/bcp.15925","volume":"90","author":"K Mehta","year":"2024","unstructured":"Mehta K, Guo T, van der Graaf PH, van Hasselt JGC. Model-based dose optimization framework for bedaquiline, pretomanid and linezolid for the treatment of drug-resistant tuberculosis. Br J Clin Pharmacol. 2024;90(2):463\u201374.","journal-title":"Br J Clin Pharmacol"},{"issue":"3","key":"525_CR10","doi-asserted-by":"publisher","first-page":"263","DOI":"10.1002\/cpdd.1515","volume":"14","author":"M Yang","year":"2025","unstructured":"Yang M, Pei Y, Chen C, Xi J, Xia Y, Zhang S, et al. Bioequivalence study of bedaquiline fumarate tablets in healthy Chinese subjects. Clin Pharmacol Drug Dev. 2025;14(3):263\u20139.","journal-title":"Clin Pharmacol Drug Dev"},{"issue":"17","key":"525_CR11","doi-asserted-by":"publisher","first-page":"1833","DOI":"10.1007\/s40265-017-0832-z","volume":"77","author":"J Deng","year":"2017","unstructured":"Deng J, Zhu X, Chen Z, Fan CH, Kwan HS, Wong CH, et al. A review of food-drug interactions on oral drug absorption. Drugs. 2017;77(17):1833\u201355.","journal-title":"Drugs"},{"key":"525_CR12","doi-asserted-by":"publisher","DOI":"10.1016\/j.dmpk.2023.100533","volume":"54","author":"Y Shirasaka","year":"2024","unstructured":"Shirasaka Y, Kambayashi A. Food effects on oral drug absorption: recent advances in understanding mechanisms and quantitative prediction. Drug Metab Pharmacokinet. 2024;54:100533.","journal-title":"Drug Metab Pharmacokinet"},{"issue":"4","key":"525_CR13","doi-asserted-by":"publisher","first-page":"292","DOI":"10.1002\/cpdd.1517","volume":"14","author":"X Wang","year":"2025","unstructured":"Wang X, Zhao X, Yang S, He K, Wen Q, Zhang W. Effect of high-fat diets on the pharmacokinetics of bedaquiline fumarate tablet: a trial in healthy Chinese participants. Clin Pharmacol Drug Dev. 2025;14(4):292\u20137.","journal-title":"Clin Pharmacol Drug Dev"},{"issue":"1","key":"525_CR14","doi-asserted-by":"publisher","first-page":"32","DOI":"10.1186\/s40249-021-00819-2","volume":"10","author":"JT Gao","year":"2021","unstructured":"Gao JT, Du J, Wu GH, Pei Y, Gao MQ, Martinez L, et al. Bedaquiline-containing regimens in patients with pulmonary multidrug-resistant tuberculosis in China: focus on the safety. Infect Dis Poverty. 2021;10(1):32.","journal-title":"Infect Dis Poverty"},{"issue":"4","key":"525_CR15","doi-asserted-by":"publisher","first-page":"345","DOI":"10.1016\/j.resinv.2019.01.001","volume":"57","author":"K Tsuyuguchi","year":"2019","unstructured":"Tsuyuguchi K, Sasaki Y, Mitarai S, Kurosawa K, Saito Y, Koh T. Safety, efficacy, and pharmacokinetics of bedaquiline in Japanese patients with pulmonary multidrug-resistant tuberculosis: an interim analysis of an open-label, phase 2 study. Respir Investig. 2019;57(4):345\u201353.","journal-title":"Respir Investig"},{"issue":"8","key":"525_CR16","doi-asserted-by":"publisher","first-page":"789","DOI":"10.5588\/ijtld.19.0586","volume":"24","author":"X Han","year":"2020","unstructured":"Han X, Chen X, Sha W, Zhang X, Qiu L, Wang J, et al. Bedaquiline in the treatment of multidrug- and extensively drug-resistant tuberculosis in China. Int J Tuberc Lung Dis. 2020;24(8):789\u201394.","journal-title":"Int J Tuberc Lung Dis"},{"issue":"5","key":"525_CR17","doi-asserted-by":"publisher","first-page":"913","DOI":"10.1111\/bcp.14199","volume":"86","author":"L Tanneau","year":"2020","unstructured":"Tanneau L, Karlsson MO, Svensson EM. Understanding the drug exposure-response relationship of bedaquiline to predict efficacy for novel dosing regimens in the treatment of multidrug-resistant tuberculosis. Br J Clin Pharmacol. 2020;86(5):913\u201322.","journal-title":"Br J Clin Pharmacol"}],"container-title":["Drugs in R&amp;D"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40268-025-00525-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40268-025-00525-6","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40268-025-00525-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,31]],"date-time":"2025-12-31T13:36:02Z","timestamp":1767188162000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40268-025-00525-6"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,31]]},"references-count":17,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2025,12]]}},"alternative-id":["525"],"URL":"https:\/\/doi.org\/10.1007\/s40268-025-00525-6","relation":{},"ISSN":["1174-5886","1179-6901"],"issn-type":[{"value":"1174-5886","type":"print"},{"value":"1179-6901","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,31]]},"assertion":[{"value":"8 July 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"28 September 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"31 October 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Yixuan Li, Yi Wu, Shufan Cai, Xiangxin Huang, Lijun Ye, Lin Wang, Yingying Zhang, Ying Wang, and Xuexia Tao declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of Interest\/Competing Interests"}},{"value":"The study was approved by the Ethics Committee for Clinical Trials of Hangzhou First People\u2019s Hospital (Approval Number: HS-BDKL-BE-05).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Approval"}},{"value":"All study participants provided written informed consent.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to Participate"}},{"value":"All researchers, participants, institutions, and sponsors consented to the submission of this report to the journal.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for Publication"}},{"value":"The datasets generated and\/or analyzed during the current study are not publicly available. However, the data that support the findings of this study are available from the corresponding author upon reasonable request.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of Data and Material"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code Availability"}},{"value":"YL, YW, and SC conceptualized and designed the study. XH and LY collected clinical trial data. LW and YZ performed data management. YL drafted the manuscript. XT and YW critically revised the manuscript and supervised the overall project. All authors reviewed the manuscript. All authors read and approved the final version of the manuscript.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors\u2019 Contributions"}}]}}