Effect of single doses of IV palonosetron, up to 2.25 mg, on the QTc interval duration: a double-blind, randomized, parallel group study in healthy volunteers

Morganroth Joel; Flaharty Kristen K.; Parisi Simona; Moresino Cecilia

首页> 外文期刊>Supportive care in cancer: official journal of the Multinational Association of Supportive Care in Cancer >Effect of single doses of IV palonosetron, up to 2.25 mg, on the QTc interval duration: a double-blind, randomized, parallel group study in healthy volunteers

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Effect of single doses of IV palonosetron, up to 2.25 mg, on the QTc interval duration: a double-blind, randomized, parallel group study in healthy volunteers

机译：单剂量IV帕洛诺司琼（高达2.25 mg）对QTc间隔持续时间的影响：健康志愿者的双盲，随机，平行分组研究

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The use of serotonin type 3 (5-HT3) receptor antagonists (RAs) in the prevention of nausea and vomiting caused by emetogenic chemotherapy is part of a comprehensive management strategy for patients undergoing chemotherapy. Electrocardiographic effects have been reported in patients after intravenous administration of 5-HT3 RAs. The present study investigated the electrocardiogram (ECG) profile of the 5-HT3 RA palonosetron following International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E14 Guidelines.

机译：使用3型血清素（5-HT3）受体拮抗剂（RAs）预防由致癌化学疗法引起的恶心和呕吐是接受化疗的患者全面治疗策略的一部分。静脉注射5-HT3 RA后，已有患者心电图报道。本研究在国际人用药品注册技术要求（ICH）E14指导原则国际会议之后调查了5-HT3 RA帕洛诺司琼的心电图（ECG）曲线。

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《Supportive care in cancer: official journal of the Multinational Association of Supportive Care in Cancer》 |2016年第2期|共7页
作者
Morganroth Joel; Flaharty Kristen K.; Parisi Simona; Moresino Cecilia;
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正文语种 eng
中图分类护理学;
关键词
Palonosetron; QTc interval; 5-HT3 receptor antagonists; Chemotherapy-induced nausea and vomiting;

机译：帕洛诺司琼;QTc间隔;5-HT3受体拮抗剂;化学疗法引起的恶心和呕吐;

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1. Effect of single doses of IV palonosetron, up to 2.25 mg, on the QTc interval duration: a double-blind, randomized, parallel group study in healthy volunteers [J] . Morganroth Joel, Flaharty Kristen K., Parisi Simona, Supportive care in cancer: official journal of the Multinational Association of Supportive Care in Cancer . 2016,第2期

机译：单剂量IV帕洛诺司琼（高达2.25 mg）对QTc间隔持续时间的影响：健康志愿者的双盲，随机，平行分组研究
2. A Randomized Study of the Single-Dose Safety, Pharmacokinetics, and Food Effect of Chinfloxacin and Its Effect on Thorough QT/QTc Interval in Healthy Chinese Volunteers [J] . Zhao Caiyun, Lv Yuan, Wei Minji, Antimicrobial agents and chemotherapy. . 2018,第12期

机译：中国富含QT / QTC间隔在健康中国志愿者中的单剂量安全，药代动力学和食物作用的随机研究
3. A Phase 1, Randomized, Placebo‐ and Active‐Controlled Crossover Study to Determine the Effect of Single‐Dose Ertugliflozin on QTc Interval in Healthy Volunteers [J] . Sahasrabudhe Vaishali, Saur Didier, Matschke Kyle, Clinical pharmacology in drug development . 2018,第5期

机译：阶段，随机，安慰剂和主动控制的交叉研究，以确定单剂量Etrugliflozin对健康志愿者QTC间隔的影响
4. A Phase I, Double-Blind, Randomized, Dose Escalating Crossover Study ofan Oral Formulation of Human Growth Hormone in Healthy Male Volunteers [C] . Steven M. Dinh, Puchun Liu, Ehud Arbit, Controlled Release Society annual meeting . 2004

机译：健康男性志愿者中人类生长激素口服制剂的I期，双盲，随机，剂量递增交叉研究
5. A double-blind, randomized comparison of the cognitive/psychomotor and inferred driving impairment side effects of a single, mild, dose of oxycodone or placebo among elderly and young individuals. [D] . Lowery, Charles D. 2005

机译：老年人和年轻人中单次，轻度剂量的羟考酮或安慰剂的认知/心理运动和推断的驾驶障碍副作用的双盲，随机比较。
6. Effect of single doses of IV palonosetron up to 2.25 mg on the QTc interval duration: a double-blind randomized parallel group study in healthy volunteers [O] . Joel Morganroth, Kristen K. Flaharty, Simona Parisi, -1

机译：单剂量IV帕洛诺司琼高达2.25 mg对QTc间隔持续时间的影响：健康志愿者的双盲随机平行分组研究
7. Effect of single doses of IV palonosetron, up to 2.25 mg, on the QTc interval duration: a double-blind, randomized, parallel group study in healthy volunteers [O] . Joel Morganroth, Kristen K. Flaharty, Simona Parisi, 2015

机译：单剂量IV帕洛诺司琼高达2.25 mg对QTc间隔持续时间的影响：健康志愿者的双盲，随机，平行分组研究

Effect of single doses of IV palonosetron, up to 2.25 mg, on the QTc interval duration: a double-blind, randomized, parallel group study in healthy volunteers

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