A Study Study to Investigate the Effect on QT/QTc Interval of Moxifloxacin After a Single Dose in Healthy Male Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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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, (therapeutic and supratherapeutic doses) to get information on effect of moxifloxacin on QT/QTc interval in healthy Korean male subjects.

Conditions

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the Effect of Moxifloxacin on QT/QTc Interval

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Moxifloxacin 400mg

moxifloxacin 400mg

Group Type EXPERIMENTAL

Moxifloxacin

Intervention Type DRUG

Moxifloxacin 800mg

moxifloxacin 800mg

Group Type EXPERIMENTAL

Moxifloxacin

Intervention Type DRUG

Placebo(No treatment)

Only drink water

Group Type PLACEBO_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Interventions

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Moxifloxacin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
* systolic blood pressure\>= 140 mmHg, diastolic blood pressure \>= 90 mmHg, heart rate \> 100 bpm or \< 50 bpm
* result of 12-lead electrocardiogram includes :

* QTcF \> 450 msec
* PR interval \> 200 msec or \<110msec
* Evidence of second- or third-degree atrioventricular (AV) block
* Pathologic Q waves (defined as Q-wave \> 40 msec or depth \> 0.5 millivolt
* Evidence of ventricular pre-excitation, left bundle branch block (LBBB), right bundle branch block (RBBB)
* Intraventricular conduction delay with QRS \> 120 msec
* risk of Torsade de pointes such as long QT syndrome, family history of sudden death, heart failure, hypokalemia
* Subjects considered unsuitable for inclusion by the investigator

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes