Tafenoquine at therapeutic concentrations does not prolong fridericia-corrected QT interval in healthy subjects
Tafenoquine at therapeutic concentrations does not prolong fridericia-corrected QT interval in healthy subjects
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DOI：
10.1002/jcph.302
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发表时间：
2014-09-01
影响因子：
2.9
通讯作者：
Miller, Ann K.
中科院分区：
文献类型：
--
作者：
Green, Justin A.;Patel, Apurva K.;Miller, Ann K.
他苯喹正在被开发用于预防间日疟原虫复发。这项I期、单盲、随机、安慰剂和主动对照的平行小组研究调查了超治疗浓度和治疗浓度的他非诺喹是否延长了健康志愿者的心脏复极。年龄在18-65岁的受试者被随机分为五个治疗组之一(n=52)，接受安慰剂、他非诺喹300、600或1200 mg，或莫西沙星400 mg(阳性对照)。如果他非诺喹1200 mg与安慰剂(QTcF)治疗后QTcF较基线变化的90%以上可信区间为
Tafenoquine is being developed for relapse prevention in Plasmodium vivax malaria. This Phase I, single-blind, randomized, placebo- and active-controlled parallel group study investigated whether tafenoquine at supratherapeutic and therapeutic concentrations prolonged cardiac repolarization in healthy volunteers. Subjects aged 18-65 years were randomized to one of five treatment groups (n=52 per group) to receive placebo, tafenoquine 300, 600, or 1200mg, or moxifloxacin 400mg (positive control). Lack of effect was demonstrated if the upper 90% CI of the change from baseline in QTcF following supratherapeutic tafenoquine 1200mg versus placebo (QTcF) was