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Vamorolone is a first\u2010generation delta\u20109,11 compound that has favorable efficacy and side effect profiles relative to classical glucocorticoids. The pharmacokinetics (PK) of oral vamorolone were assessed in parallel\u2010group studies in healthy men (phase 1, n = 86) and boys with DMD (phase 2a, n = 48) during 14 days of once\u2010daily dosing with a range of doses. Vamorolone exhibited moderate variability in PK, with the maximum plasma concentration usually occurring at 2\u20104 hours and a half\u2010life of approximately 2 hours for all doses and days examined. Population PK modeling of all data together indicated that the PK of vamorolone can be well described by a 1\u2010compartment model with zero\u2010order absorption. Both men and boys showed a dose\u2010linearity of PK parameters for the doses examined, with no accumulation of the drug during daily dosing. Ingestion with food resulted in markedly enhanced absorption of the drug, as tested in healthy men. There were similar PK of vamorolone in healthy men and DMD boys with apparent clearance averaging 2.0 L\/h\/kg in men and 1.7 L\/h\/kg in boys. Overall, vamorolone exhibited well\u2010behaved linear PK, with similar profiles in healthy men and boys with DMD, moderate variability in PK parameters, and absorption and disposition profiles similar to those of classical glucocorticoids.<\/jats:p>","DOI":"10.1002\/jcph.1388","type":"journal-article","created":{"date-parts":[[2019,2,11]],"date-time":"2019-02-11T16:48:43Z","timestamp":1549903723000},"page":"979-988","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Population Pharmacokinetics of Vamorolone (VBP15) in Healthy Men and Boys With Duchenne Muscular Dystrophy"],"prefix":"10.1002","volume":"59","author":[{"given":"Panteleimon D.","family":"Mavroudis","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Sciences University at Buffalo State University of New York  Buffalo NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"van den 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