{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,22]],"date-time":"2025-10-22T00:45:12Z","timestamp":1761093912375,"version":"build-2065373602"},"reference-count":20,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2012,1,6]],"date-time":"2012-01-06T00:00:00Z","timestamp":1325808000000},"content-version":"vor","delay-in-days":1650,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accpjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacotherapy"],"published-print":{"date-parts":[[2007,7]]},"abstract":"<jats:p><jats:bold>Study Objective<\/jats:bold>. To evaluate the effect of an aluminum\u2010 and magnesium\u2010containing antacid (Al\u2010Mg antacid), which contains a high concentration of cations, on the pharmacokinetics of garenoxacin.<\/jats:p><jats:p><jats:bold>Design<\/jats:bold>. Prospective, randomized, open\u2010label, control\u2010balanced, residual\u2010effects\u2014design study.<\/jats:p><jats:p><jats:bold>Setting<\/jats:bold>. Pharmaceutical company\u2014affiliated study clinic.<\/jats:p><jats:p><jats:bold>Subjects<\/jats:bold>. Twenty healthy volunteers who were garenoxacin na\u00efve.<\/jats:p><jats:p><jats:bold>Intervention<\/jats:bold>. Subjects were randomly assigned to receive three of six oral treatments, each separated by a 7\u2010day washout period: garenoxacin 600 mg administered alone, with concomitant Al\u2010Mg antacid, 2 or 4 hours before Al\u2010Mg antacid, or 2 or 4 hours after Al\u2010Mg antacid. The Al\u2010Mg antacid dose was 20 ml, which contained aluminum hydroxide 900 mg and magnesium hydroxide 800 mg.<\/jats:p><jats:p><jats:bold>Measurements and Main Results<\/jats:bold>. The pharmacokinetics and safety of garenoxacin were assessed. For each treatment, serial blood samples for pharmacokinetic analysis of garenoxacin were collected before and up to 72 hours after garenoxacin dosing. Absence of effect of Al\u2010Mg antacid on garenoxacin area under the concentration\u2010time curve from time zero extrapolated to infinity (AUC<jats:sub>0\u2013\u221e<\/jats:sub>) and maximum observed plasma concentration (C<jats:sub>max<\/jats:sub>) were concluded if the 90% confidence interval of the adjusted geometric mean ratios with and without the antacid were contained within 0.80\u20131.25 and 0.70\u20131.43, respectively. Exposure to garenoxacin measured by AUC<jats:sub>0\u2013\u221e<\/jats:sub>, a parameter well correlated with efficacy, was reduced by 58% when coadministered with Al\u2010Mg antacid and reduced by 22% and 16% when administered 2 and 4 hours after the antacid, respectively. Administration of garenoxacin 4 hours before Al\u2010Mg antacid had no effect on AUC<jats:sub>0\u2013\u221e<\/jats:sub> or C<jats:sub>max<\/jats:sub> of garenoxacin, whereas administration 2 hours before the antacid resulted in a nonclinically relevant (12%) reduction in AUC<jats:sub>0\u2013\u221e<\/jats:sub> of garenoxacin.<\/jats:p><jats:p><jats:bold>Conclusion<\/jats:bold>. Exposure to garenoxacin was significantly decreased when garenoxacin was coadministered with Al\u2010Mg antacid or within 2 hours after the antacid. The magnitude of the changes in garenoxacin exposure suggests that garenoxacin should be administered at least 2 hours before or 4 hours after administration of Al\u2010Mg antacid or other cation\u2010containing products.<\/jats:p>","DOI":"10.1592\/phco.27.7.963","type":"journal-article","created":{"date-parts":[[2007,6,26]],"date-time":"2007-06-26T11:00:02Z","timestamp":1182855602000},"page":"963-969","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Effect of an Aluminum\u2010 and Magnesium\u2010Containing Antacid on the Bioavailability of Garenoxacin in Healthy Volunteers"],"prefix":"10.1002","volume":"27","author":[{"given":"Gopal","family":"Krishna","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James C.","family":"Kisicki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steven","family":"Olsen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dennis M.","family":"Grasela","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zaiqi","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2012,1,6]]},"reference":[{"key":"e_1_2_1_2_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.48.12.4766-4777.2004"},{"key":"e_1_2_1_3_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.48.3.765-773.2004"},{"key":"e_1_2_1_4_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.45.2.589-592.2001"},{"key":"e_1_2_1_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0732-8893(03)00002-6"},{"key":"e_1_2_1_6_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.47.11.3539-3541.2003"},{"key":"e_1_2_1_7_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.47.7.2256-2263.2003"},{"key":"e_1_2_1_8_2","first-page":"8","volume-title":"Safety, tolerability and pharmacokinetics of BMS\u2010284756, a novel des\u2010F(6)\u2010quinolone, following 28 days of once\u2010daily oral dosing in healthy subjects [abstract]","author":"Stewart C.","year":"2001"},{"key":"e_1_2_1_9_2","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkg110"},{"key":"e_1_2_1_10_2","first-page":"19","volume-title":"Lack of effect of intravenous BMS\u2010284756 on the QTc interval in healthy subjects [abstract]","author":"Gajjar D.","year":"2001"},{"key":"e_1_2_1_11_2","doi-asserted-by":"publisher","DOI":"10.1159\/000007245"},{"key":"e_1_2_1_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0149-2918(98)80110-0"},{"key":"e_1_2_1_13_2","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/34.4.465"},{"key":"e_1_2_1_14_2","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.1989.207"},{"key":"e_1_2_1_15_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.36.10.2270"},{"key":"e_1_2_1_16_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.36.6.1219"},{"key":"e_1_2_1_17_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.37.10.2173"},{"key":"e_1_2_1_18_2","doi-asserted-by":"publisher","DOI":"10.1177\/106002809102501115"},{"key":"e_1_2_1_19_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.chroma.2005.02.057"},{"key":"e_1_2_1_20_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.chroma.2005.02.016"},{"key":"e_1_2_1_21_2","doi-asserted-by":"publisher","DOI":"10.1086\/516284"}],"container-title":["Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1592%2Fphco.27.7.963","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accpjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1592\/phco.27.7.963","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,21]],"date-time":"2025-10-21T13:26:25Z","timestamp":1761053185000},"score":1,"resource":{"primary":{"URL":"https:\/\/accpjournals.onlinelibrary.wiley.com\/doi\/10.1592\/phco.27.7.963"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2007,7]]},"references-count":20,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2007,7]]}},"alternative-id":["10.1592\/phco.27.7.963"],"URL":"https:\/\/doi.org\/10.1592\/phco.27.7.963","archive":["Portico"],"relation":{},"ISSN":["0277-0008","1875-9114"],"issn-type":[{"type":"print","value":"0277-0008"},{"type":"electronic","value":"1875-9114"}],"subject":[],"published":{"date-parts":[[2007,7]]},"assertion":[{"value":"2012-01-06","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}