A Study Study to Investigate the Effect on QT/QTc Interval of Moxifloxacin After a Single Dose in Healthy Male Subjects
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The purpose of this study is to evaluate effect of moxifloxacin on QT/QTc interval in healthy male subjects. Moxifloxacin is a positive control drug used in QT study. In this study, moxifloxacin 400mg and 800mg will be used, to get information on effect of moxifloxacin on QT/QTc interval.
Condition or disease
the Effect of Moxifloxacin on QT/QTc Interval
The purpose of this study is to evaluate effect of moxifloxacin on QT/QTc interval in healthy male subjects. Moxifloxacin is a positive control drug used in QT study. In this study, moxifloxacin 400mg and 800mg will be used, (therapeutic and supratherapeutic doses) to get information on effect of moxifloxacin on QT/QTc interval in healthy Korean male subjects.
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Ages Eligible for Study:
20 Years to 40 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
healthy male subject aged 20 to 40 at screening
subjects who have weight over 50 kg with ideal body weight range of +- 20%
subjects who decide to participate voluntarily and write a informed consent form
subjects who have acute illness within 28 days of investigational drug administration
subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
subjects who have determined not eligible by screening test (medical history, physical examination, 12-lead ECG, laboratory test, etc) within 28 days of study start
clinically significant allergic disease (except for mild allergic rhinitis)