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The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects

Information source: Inje University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Moxifloxacin (Drug); Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Inje University

Official(s) and/or principal investigator(s):
Jae-Gook Shin, MD, PhD, Principal Investigator, Affiliation: Inje University


The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects

Clinical Details

Official title: A Randomized, Double-blind, Placebo-controlled, Two-way Crossover Trial to Compare Moxifloxacin Induced QT Interval Prolongation in Japanese and Korean Healthy Subjects

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Primary outcome: double delta QTcF

Secondary outcome: double delta QTcI, double delta QTcSS

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.


Minimum age: 20 Years. Maximum age: 35 Years. Gender(s): Both.


Inclusion Criteria:

- 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 Criteria:

- 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

Locations and Contacts

Additional Information

Starting date: November 2011
Last updated: June 11, 2013

Page last updated: August 23, 2015

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