{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T14:17:22Z","timestamp":1783606642619,"version":"3.55.0"},"reference-count":25,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2022,4,21]],"date-time":"2022-04-21T00:00:00Z","timestamp":1650499200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100002855","name":"Ministry of Science and Technology of the People\u2019s Republic of China","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100002855","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pharmacol."],"abstract":"<jats:p><jats:bold>Objective:<\/jats:bold> Omadacycline is a new type of aminomethylcycline antibiotic, having a broad antibacterial spectrum. But the pharmacokinetic characteristics and safety profile of the Chinese population remain unknown. It is also unclear whether the US-approved treatment regimen is applicable for the Chinese population.<\/jats:p><jats:p><jats:bold>Methods:<\/jats:bold> In a randomized, double-blinded, placebo-controlled dose-escalated trial, the pharmacokinetics of omadacycline was evaluated by a non-compartmental and compartmental model. Monte Carlo simulations were performed using the pharmacokinetic data from the Chinese population to evaluate the probability of target attainment (PTA) and the cumulative fraction of response (CFR) of the US FDA-approved dose regimen.<\/jats:p><jats:p><jats:bold>Results:<\/jats:bold> The three-compartment model successfully described the rapid distribution and slow elimination of omadacycline after the intravenous infusion (i.v.). The double-peak concentration-time curve of the oral absorption (p.o.) was explained by the two-compartment model with two absorption compartments. The steady-state AUC of 100\u00a0mg omadacycline i.v. and 300\u00a0mg omadacycline p. o. were 12.1 and 19.4\u00a0mg\u00a0h\/L, respectively. Pharmacokinetics\/pharmacodynamics (PK\/PD) analysis showed that the omadacycline dosing regimen with a loading dose (200\u00a0mg i.v. q24\u00a0h, 100\u00a0mg i.v. q12\u00a0h, 450\u00a0mg p. o. q24\u00a0h \u00d7 2\u00a0days or 300\u00a0mg p. o. q12\u00a0h) and maintenance dose (100\u00a0mg i.v. q24\u00a0h or 300\u00a0mg p. o. q24\u00a0h) could cover the main pathogens of the indications acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP): <jats:italic>Staphylococcus aureus<\/jats:italic> and <jats:italic>Streptococcus pneumoniae<\/jats:italic>. Also, omadacycline had showed a good safety profile in the Chinese population.<\/jats:p><jats:p><jats:bold>Conclusions:<\/jats:bold> With the evidence provided, omadacycline could be a novel treatment option to Chinese patients with ABSSSI and CABP.<\/jats:p>","DOI":"10.3389\/fphar.2022.869237","type":"journal-article","created":{"date-parts":[[2022,4,21]],"date-time":"2022-04-21T04:57:42Z","timestamp":1650517062000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":9,"title":["Pharmacokinetics, Safety and Pharmacokinetics\/Pharmacodynamics Analysis of Omadacycline in Chinese Healthy Subjects"],"prefix":"10.3389","volume":"13","author":[{"given":"Haijing","family":"Yang","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhiwei","family":"Huang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuancheng","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yusong","family":"Zhu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guoying","family":"Cao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jingjing","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan","family":"Guo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jicheng","family":"Yu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jufang","family":"Wu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lichuan","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun","family":"Deng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harald","family":"Reinhart","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaojie","family":"Wu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2022,4,21]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"S23","DOI":"10.1093\/cid\/ciz396","article-title":"Omadacycline for Acute Bacterial Skin and Skin Structure Infections","volume":"69","author":"Abrahamian","year":"2019","journal-title":"Clin. 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