{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T21:22:28Z","timestamp":1790803348358,"version":"4.1.0"},"reference-count":9,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2013,3,7]],"date-time":"2013-03-07T00:00:00Z","timestamp":1362614400000},"content-version":"vor","delay-in-days":2076,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2007,7]]},"abstract":"<jats:p>Rifalazil is a new antibiotic structurally related to rifampin but devoid of the metabolic liabilities typically associated with the rifamycin class of antibiotics. A randomized, 3\u2010way crossover study in healthy male volunteers (n = 12) investigated the safety and pharmacokinetics of a single 25\u2010mg oral rifalazil dose administered under a standard breakfast containing fat as 30% of calories, a high\u2010fat breakfast containing fat as 60% of calories, and an overnight fast of 10 hours with a 21\u2010 to 28\u2010day washout between doses. Systemic exposure to rifalazil based on C<jats:sub>max<\/jats:sub>, AUC<jats:sub>0\u2010Tlast<\/jats:sub>, and AUC<jats:sub>0\u2010\u221e<\/jats:sub> was increased progressively as the fat content of the test breakfast was increased from 30% to 60% compared with fasting. The confidence intervals for both fat\u2010containing breakfasts are outside the limits of 80% to 125% allowed for food effect bioequivalence based on C<jats:sub>max<\/jats:sub>, AUC<jats:sub>0\u2010Tlast<\/jats:sub>, and AUC<jats:sub>0\u2010\u221e<\/jats:sub>. This food effect may be a result of increased fractional absorption with increasing dietary fat content. Another striking finding was the large reduction of the pharmacokinetic intersubject variability after rifalazil administration with food. Rifalazil was safe and well tolerated under fed and fasted conditions.<\/jats:p>","DOI":"10.1177\/0091270007300745","type":"journal-article","created":{"date-parts":[[2007,6,20]],"date-time":"2007-06-20T21:09:21Z","timestamp":1182373761000},"page":"841-849","source":"Crossref","is-referenced-by-count":14,"title":["Effect of Food on the Pharmacokinetics of Rifalazil, a Novel Antibacterial, in Healthy Male Volunteers"],"prefix":"10.1002","volume":"47","author":[{"given":"Y.\u2010X.","family":"Chen","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B.","family":"Cabana","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N.","family":"Kivel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Michaelis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2013,3,7]]},"reference":[{"key":"e_1_2_6_2_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.39.7.1489"},{"key":"e_1_2_6_3_2","doi-asserted-by":"publisher","DOI":"10.1517\/13543784.12.2.255"},{"key":"e_1_2_6_4_2","doi-asserted-by":"crossref","first-page":"2749","DOI":"10.1128\/AAC.40.12.2749","article-title":"Pharmacokinetics of KRM\u20101648, a new benzoxazinorifamycin, in rats and dogs","volume":"40","author":"Hosoe K","year":"1996","journal-title":"Antimicrob Agents Chemother"},{"key":"e_1_2_6_5_2","doi-asserted-by":"publisher","DOI":"10.1080\/004982599237967"},{"key":"e_1_2_6_6_2","doi-asserted-by":"publisher","DOI":"10.1080\/004982500406408"},{"key":"e_1_2_6_7_2","doi-asserted-by":"publisher","DOI":"10.1080\/004982598239173"},{"key":"e_1_2_6_8_2","volume-title":"Pharmacokinetics","author":"Gibaldi M","year":"1975"},{"key":"e_1_2_6_9_2","volume-title":"Fundamentals of Clinical Pharmacokinetics","author":"Wagner JG.","year":"1975"},{"key":"e_1_2_6_10_2","doi-asserted-by":"crossref","first-page":"529","DOI":"10.1038\/jid.1961.154","article-title":"Human pharmacology of griseofluvin: the effect of fat intake on gastrointestinal absorption","volume":"37","author":"Crounse RG.","year":"1961","journal-title":"J Invest Dematol"}],"container-title":["The Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1177%2F0091270007300745","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1177\/0091270007300745","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,12]],"date-time":"2023-10-12T20:45:04Z","timestamp":1697143504000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1177\/0091270007300745"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2007,7]]},"references-count":9,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2007,7]]}},"alternative-id":["10.1177\/0091270007300745"],"URL":"https:\/\/doi.org\/10.1177\/0091270007300745","archive":["Portico"],"relation":{},"ISSN":["0091-2700","1552-4604"],"issn-type":[{"value":"0091-2700","type":"print"},{"value":"1552-4604","type":"electronic"}],"subject":[],"published":{"date-parts":[[2007,7]]}}}