JPRN-UMIN000015502已完成未知
A Single-dose, Randomized, Placebo-controlled, Two-period Crossover Study of the Effects of Moxifloxacin on the ECG Intervals in Healthy Japanese and Caucasian Subjects at Two Sites: Focus on the Role of Ethnicity on Cardiac Repolarization - QT-E1
Kitasato University East Hospital0 个研究点目标入组 80 人开始时间: 2014年10月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18years-old 至 45years-old（—）
- 性别
- Male
入选标准
- 未提供
排除标准
- •1.Past or present diseases, which as judged by the investigator, may affect the outcome of this study, include, but not limited to, significant medical abnormality including: psychiatric, neurologic, pulmonary, cardiac, gastrointestinal, genitourinary, renal, metabolic, endocrinologic, or autoimmune disorder 2.Positive for HIV, hepatitis B and/or hepatitis C at screening 3.Family history of QTc prolongation or of unexplainable sudden death at <50 years of age 4.Knowledge of any kind of cardiovascular disorder/condition known to increase the possibility of QT prolongation or history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome or Brugada Syndrome) or cardiac conduction disorders 5.Any condition that may interfere with the absorption, metabolism, or elimination of the study drug 6.History of, or active, alcohol or illicit drug abuse. Alcohol abuse is defined as an average intake of three or more drinks (12 oz beer, 1.5 oz of hard liquor, or equivalent) per day 7.Tobacco use (chewed or smoked) unless abstinent for at least one month 8.Laboratory safety test results that are outside of the normal reference ranges (unless clinically acceptable to the Principal Investigator) or are clinically significant abnormalities as determined by the Principal Investigator 9.At screening: resting supine heart rate less than 50 beats per minute or greater than 100 beats per minute (may be repeated once at the discretion of the Investigator). Minor deviations will be acceptable if considered to be of no clinical significance by the Investigator. 10.At screening: resting supine systolic blood pressure less than 90 mmHg or greater than 140 mmHg; resting supine diastolic blood pressure less than 50 mmHg or greater than 90 mmHg. Blood pressure measurements may be repeated once at the discretion of the Investigator.
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