{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,30]],"date-time":"2025-10-30T22:28:18Z","timestamp":1761863298829},"reference-count":14,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2014,4,15]],"date-time":"2014-04-15T00:00:00Z","timestamp":1397520000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Romark Laboratories, L.C."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2014,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:label \/><jats:p>In this randomized, double\u2010blind, placebo controlled study, the safety of therapeutic (675\u2009mg) and supra\u2010therapeutic (2,700\u2009mg) doses of nitazoxanide was evaluated in accordance with the ICH E14 guidelines. Fifty six (56) subjects participated in four treatment periods and received single doses of nitazoxanide 675\u2009mg, nitazoxanide 2,700\u2009mg, moxifloxacin 400\u2009mg, or placebo. For 675\u2009mg nitazoxanide, the largest change in QTcF from baseline was observed at 12\u2009hours post\u2010dose with a peak value of 1.6\u2009ms (two\u2010sided 90% CI: \u22120.3, 3.6\u2009ms). The largest negative change in QTcF was observed at 1\u2009hour post\u2010dose (\u22122.7\u2009ms with two\u2010sided 90% CI: \u22124.5, \u22120.8\u2009ms). The largest change in QTcF from baseline for 2,700\u2009mg nitazoxanide was observed at 24\u2009hours post\u2010dose with a peak value of 3.4\u2009ms (two\u2010sided CI: 1.4, 5.4\u2009ms). These findings demonstrate that neither a single dose of 675\u2009mg nor 2,700\u2009mg nitazoxanide prolonged the QT interval in healthy male and female volunteers. The safety results also demonstrate that all four treatments were well\u2010tolerated and the most frequently reported adverse events in the nitazoxanide and moxifloxacin treatment groups were gastrointestinal disorders which were as expected according to the reference safety information.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcph.300","type":"journal-article","created":{"date-parts":[[2014,4,1]],"date-time":"2014-04-01T11:10:27Z","timestamp":1396350627000},"page":"987-994","source":"Crossref","is-referenced-by-count":6,"title":["Analyzing the relationship of QT interval and exposure to <i>Nitazoxanide<\/i>, a prospective candidate for influenza antiviral therapy\u2014A formal TQT study"],"prefix":"10.1002","volume":"54","author":[{"given":"J\u00f6rg","family":"T\u00e4ubel","sequence":"first","affiliation":[{"name":"Richmond Pharmacology Ltd. St George's University of London, Cranmer Terrace London UK"},{"name":"Department of Cardiological Sciences St George's University of London, Cranmer Terrace London UK"}]},{"given":"Ulrike","family":"Lorch","sequence":"additional","affiliation":[{"name":"Richmond Pharmacology Ltd. St George's University of London, Cranmer Terrace London UK"}]},{"given":"Jean\u2010Fran\u00e7ois","family":"Rossignol","sequence":"additional","affiliation":[{"name":"The Romark Institute for Medical Research 3000 Bayport Drive, Suite 200 Tampa FL 33607 USA"}]},{"given":"Georg","family":"Ferber","sequence":"additional","affiliation":[{"name":"Richmond Pharmacology Ltd. St George's University of London, Cranmer Terrace London UK"}]},{"given":"A.","family":"John Camm","sequence":"additional","affiliation":[{"name":"Department of Cardiological Sciences St George's University of London, Cranmer Terrace London UK"}]}],"member":"311","published-online":{"date-parts":[[2014,4,15]]},"reference":[{"key":"e_1_2_8_2_1","first-page":"187","article-title":"Influenza treatment and prophylaxis with neuraminidase inhibitors: a review","volume":"6","author":"Kamali A","year":"2013","journal-title":"Infect Drug Resist"},{"key":"e_1_2_8_3_1","unstructured":"RossignolJF CavierR. New derivative of 2\u2010benzamido\u20105\u2010nitro thiazoles. Patent US. 3950351 (1976)."},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1074\/jbc.M109.029470"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(14)70717-0"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.5414\/CPP40221"},{"key":"e_1_2_8_7_1","unstructured":"ICH E 14. 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