{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T06:26:28Z","timestamp":1789453588854,"version":"build-2803163510"},"reference-count":38,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2015,7,2]],"date-time":"2015-07-02T00:00:00Z","timestamp":1435795200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2015,9]]},"abstract":"<jats:sec><jats:title>Aim<\/jats:title><jats:p>We investigated whether moxifloxacin\u2010induced QT<jats:sub>c<\/jats:sub> prolongations in Japanese and Caucasian healthy male volunteers were significantly different.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A two period, randomized, crossover, ICH\u2010E14\u2010compliant thorough QT (TQT) study compared placebo\u2010corrected changes in QT<jats:sub>c<\/jats:sub> interval from baseline (\u0394\u0394QT<jats:sub>c<\/jats:sub>F) and concentration\u2013effect relationships following administration of placebo and 400 mg moxifloxacin to 40 healthy male volunteers from each ethnic population. The point estimates of \u0394\u0394QT<jats:sub>c<\/jats:sub>F for each population, and the difference between the two, were calculated at a geometric mean <jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub> of moxifloxacin using a linear mixed effects model. The concentration\u2013effect slopes of the two populations were also compared. Equivalence was concluded if the two\u2010sided 90% confidence interval of the difference in \u0394\u0394QT<jats:sub>c<\/jats:sub>F was contained within \u22125 ms to +5 ms limits and the ratio of the slopes was between 0.5 and 2.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>There were no statistically significant differences between the two populations studied, Japanese <jats:italic>vs<\/jats:italic>. Caucasians, respectively, for moxifloxacin <jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub> (3.27 \u00b1 0.6 <jats:italic>vs<\/jats:italic>. 2.98 \u00b1 0.7 \u00b5g ml<jats:sup>\u20131<\/jats:sup>), \u0394\u0394QT<jats:sub>c<\/jats:sub>F (9.63 \u00b1 1.15 <jats:italic>vs<\/jats:italic>. 11.46 \u00b1 1.19 ms at <jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub> of 3.07 \u00b5g ml<jats:sup>\u20131<\/jats:sup>) and concentration\u2013response slopes (2.58 \u00b1 0.62 <jats:italic>vs<\/jats:italic>. 2.34 \u00b1 0.64 ms per \u00b5g ml<jats:sup>\u20131<\/jats:sup>). The difference in the two \u0394\u0394QT<jats:sub>c<\/jats:sub>F of \u22121.8 (90% CI \u22124.6, 0.9) and the ratio of the two slopes (1.1; 90% CI 0.63, 1.82) were within pre\u2010specified equivalence limits.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Moxifloxacin\u2010induced QT<jats:sub>c<\/jats:sub> prolongations did not differ significantly between the Japanese and Caucasian subjects. However, before our findings are more widely generalized, further studies in other populations and with other QT\u2010prolonging drugs are needed to clarify whether inter\u2010ethnic differences in QT sensitivity exist and whether ethnicity of the study population may affect the outcome of a TQT study.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.12684","type":"journal-article","created":{"date-parts":[[2015,5,23]],"date-time":"2015-05-23T01:03:59Z","timestamp":1432343039000},"page":"446-459","source":"Crossref","is-referenced-by-count":20,"title":["Moxifloxacin\u2010induced QT<sub>c<\/sub> interval prolongations in healthy male Japanese and Caucasian volunteers: a direct comparison in a thorough QT study"],"prefix":"10.1111","volume":"80","author":[{"given":"Joel","family":"Morganroth","sequence":"first","affiliation":[{"name":"EResearch Technology Inc.  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Miami Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Norman","family":"Stockbridge","sequence":"additional","affiliation":[{"name":"Division of Cardiovascular and Renal Products Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Kleiman","sequence":"additional","affiliation":[{"name":"EResearch Technology Inc.  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