Status:
COMPLETED
The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects
Lead Sponsor:
Inje University
Conditions:
Healthy
Eligibility:
All Genders
20-35 years
Phase:
NA
Brief Summary
The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects
Detailed Description
The purpose of this study is to explore the ethnic and gender difference in the Moxifloxacin induced QT interval prolongation between Japanese and Korean subjects.
Eligibility Criteria
Inclusion
- \- 1) Subjects in Japan and Korea deemed healthy as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, or clinical laboratory determinations.
- 2\) Body Mass Index (BMI) of 17.6 to 26.4 kg/m2, BMI = weight (kg)/ \[height (m)\]2.
Exclusion
- 1\) Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
- 2\) Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat.
- Heart rate ≤ 45 bpmmsec or Heart rate ≥ 100 bpmmsec
- PR ≥ 210 msec
- QRS ≥ 120 msec
- QT ≥ 500 msec
- QTcF: male ≥ 450 msec, female ≥470msec
- Iincomplete right bundle branch block
- Marked Sinus Arrhythmia
- Wondering pacemaker
- Atrial rhythm
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01876316
Start Date
November 1 2011
End Date
January 1 2013
Last Update
June 12 2013
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