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Mirogabalin or placebo was administered alone or with single\u2010dose lorazepam, zolpidem, tramadol, ethanol, or interacting drug placebo. Safety was assessed and serial samples for pharmacokinetic parameters were collected for up to 48 hours postdose. PD assessments included body sway (except tramadol), digit symbol substitution test, vertigo symptom scale short form, brief ataxia rating scale, and the Bond and Lader visual analog scale. Coadministration of mirogabalin with any of the 4 drugs did not cause any clinically relevant pharmacokinetic interactions. Peak mirogabalin concentration decreased by 28% (least squares mean ratio, 0.72; 90% confidence interval, [CI] 0.67, 0.76) following tramadol coadministration, and increased by 20% (least squares mean ratio, 1.20; 90%CI, 1.12, 1.28) following ethanol coadministration. Mirogabalin alone had little to no effect on PD parameters, but coadministration of mirogabalin with either lorazepam or ethanol increased the PD effects in body sway and digit symbol substitution test assays. Mirogabalin\/lorazepam and mirogabalin\/zolpidem increased occurrence of somnolence. Increased incidence of nausea and headache was noted with mirogabalin\/tramadol and mirogabalin\/ethanol, respectively.<\/jats:p>","DOI":"10.1002\/cpdd.582","type":"journal-article","created":{"date-parts":[[2018,6,5]],"date-time":"2018-06-05T16:32:12Z","timestamp":1528216332000},"page":"597-612","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Mirogabalin When Coadministered With Lorazepam, Zolpidem, Tramadol, or Ethanol: Results From Drug\u2010Drug Interaction Studies in Healthy Subjects"],"prefix":"10.1002","volume":"7","author":[{"given":"Mendel","family":"Jansen","sequence":"first","affiliation":[{"name":"Daiichi Sankyo Development Ltd Gerrards Cross  Buckinghamshire UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeanne","family":"Mendell","sequence":"additional","affiliation":[{"name":"Daiichi Sankyo Pharma Development Basking Ridge  NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexander","family":"Currie","sequence":"additional","affiliation":[{"name":"Daiichi Sankyo Development Ltd Gerrards Cross  Buckinghamshire UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James","family":"Dow","sequence":"additional","affiliation":[{"name":"Daiichi Sankyo Development Ltd Gerrards Cross  Buckinghamshire UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ling","family":"He","sequence":"additional","affiliation":[{"name":"Daiichi Sankyo Pharma Development Basking Ridge  NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Domenico","family":"Merante","sequence":"additional","affiliation":[{"name":"Daiichi Sankyo Development Ltd Gerrards Cross  Buckinghamshire UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Victor","family":"Dishy","sequence":"additional","affiliation":[{"name":"Daiichi Sankyo Pharma Development Basking Ridge  NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hitoshi","family":"Ishizuka","sequence":"additional","affiliation":[{"name":"Daiichi Sankyo Co., Ltd.  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