{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T16:51:52Z","timestamp":1793379112186,"version":"4.5.0"},"reference-count":33,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2016,1,14]],"date-time":"2016-01-14T00:00:00Z","timestamp":1452729600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100000801","name":"Bayer HealthCare","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000801","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Fundamemntal Clinical Pharma"],"published-print":{"date-parts":[[2016,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    The safety, tolerability and pharmacokinetics of the selective nonsteroidal mineralocorticoid receptor antagonist finerenone were evaluated in healthy male volunteers in two randomized, single\u2010centre studies. Study 1 was a first\u2010in\u2010man, single\u2010blinded, placebo\u2010controlled, parallel\u2010group, dose\u2010escalation study. Fasted participants (\n                    <jats:italic>n<\/jats:italic>\n                    = 45) received single oral doses of finerenone 1\u201340 mg polyethylene glycol (\n                    <jats:styled-content style=\"fixed-case\">PEG<\/jats:styled-content>\n                    ) solution or placebo. Study 2 was a relative bioavailability study comparing a finerenone 10 mg immediate\u2010release (\n                    <jats:styled-content style=\"fixed-case\">IR<\/jats:styled-content>\n                    ) tablet with finerenone 10 mg\n                    <jats:styled-content style=\"fixed-case\">PEG<\/jats:styled-content>\n                    solution in the fasted state, investigating the effect of a high\u2010fat\/high\u2010calorie meal on the pharmacokinetics of the\n                    <jats:styled-content style=\"fixed-case\">IR<\/jats:styled-content>\n                    tablet and assessing a further dose escalation to finerenone 80 mg (eight \u00d7 finerenone 10 mg\n                    <jats:styled-content style=\"fixed-case\">IR<\/jats:styled-content>\n                    tablets), in an open\u2010label, fourfold crossover design (\n                    <jats:italic>n<\/jats:italic>\n                    = 15). Finerenone was rapidly absorbed from\n                    <jats:styled-content style=\"fixed-case\">PEG<\/jats:styled-content>\n                    solution (median time to maximum plasma concentration [\n                    <jats:italic>t<\/jats:italic>\n                    <jats:sub>max<\/jats:sub>\n                    ]: 0.500\u20131.00 h), exhibited dose\u2010linear pharmacokinetics and was rapidly eliminated from plasma (geometric mean terminal half\u2010life [\n                    <jats:italic>t<\/jats:italic>\n                    <jats:sub>\u00bd<\/jats:sub>\n                    ]: 1.70\u20132.83 h). Finerenone\n                    <jats:styled-content style=\"fixed-case\">IR<\/jats:styled-content>\n                    tablets demonstrated similar pharmacokinetics (median\n                    <jats:italic>t<\/jats:italic>\n                    <jats:sub>max<\/jats:sub>\n                    : 0.750\u20132.50 h; geometric mean\n                    <jats:italic>t<\/jats:italic>\n                    <jats:sub>\u00bd<\/jats:sub>\n                    : 1.89\u20134.29 h) with, however, enhanced bioavailability versus\n                    <jats:styled-content style=\"fixed-case\">PEG<\/jats:styled-content>\n                    solution (least\u2010squares mean tablet\/solution ratio of 187% for area under the plasma\u2013concentration curve [\n                    <jats:styled-content style=\"fixed-case\">AUC<\/jats:styled-content>\n                    ] and maximum plasma concentration [\n                    <jats:italic>C<\/jats:italic>\n                    <jats:sub>max<\/jats:sub>\n                    ]). High\u2010fat\/high\u2010calorie food affected the rate but not the extent of finerenone absorption. Finerenone was well tolerated and did not influence clinical laboratory parameters, blood pressure, heart rate, urinary electrolytes or neurohormones, including serum aldosterone and angiotensin\n                    <jats:styled-content style=\"fixed-case\">II<\/jats:styled-content>\n                    . In conclusion, finerenone has favourable pharmacokinetics and tolerability in healthy men, and is suitable for dosing independent of food intake.\n                  <\/jats:p>","DOI":"10.1111\/fcp.12170","type":"journal-article","created":{"date-parts":[[2015,11,25]],"date-time":"2015-11-25T03:04:55Z","timestamp":1448420695000},"page":"172-184","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":60,"title":["Pharmacokinetics, safety and tolerability of the novel, selective mineralocorticoid receptor antagonist finerenone \u2013 results from first\u2010in\u2010man and relative bioavailability studies"],"prefix":"10.1111","volume":"30","author":[{"given":"Silvia","family":"Lentini","sequence":"first","affiliation":[{"name":"Clinical Sciences Clinical Pharmacology Cardiovascular and Hematology, Bayer Pharma AG, Pharma Research Centre 42096 Wuppertal Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roland","family":"Heinig","sequence":"additional","affiliation":[{"name":"Clinical Sciences Clinical Pharmacology Cardiovascular and Hematology, Bayer Pharma AG, Pharma Research Centre 42096 Wuppertal Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nina","family":"Kimmeskamp\u2010Kirschbaum","sequence":"additional","affiliation":[{"name":"Global Research &amp; Development Statistics Bayer Pharma AG Pharma Research Centre 42096 Wuppertal Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Georg","family":"Wensing","sequence":"additional","affiliation":[{"name":"Clinical Sciences Clinical Pharmacology Cardiovascular and Hematology, Bayer Pharma AG, Pharma Research Centre 42096 Wuppertal Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2016,1,14]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.103.1.72"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/16.suppl_N.98"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.82.5.1730"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1172\/JCI118867"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1749-6632.2002.tb04415.x"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1523-1755.2004.00701.x"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.HYP.0000022606.52221.2F"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0895-7061(03)00913-0"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199909023411001"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa030207"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1009492"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD007004.pub2"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.ajkd.2007.10.040"},{"key":"e_1_2_6_15_1","unstructured":"American College of Cardiology Foundation\/American Heart Association Task Force on Practice Guidelines.2013ACCF\/AHA Guideline for the Management of Heart Failure. 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