Skip to main content
OpenTrials
Completed

NCT Number: NCT01876316

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.
  • 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

Treatment and study plan

moxifloxacin

Drug

single oral administration of 400mg of moxifloxacin

Other names: Avelox

Placebo

Drug

single oral administration of 400mg of placebo

Other names: Lactose

Primary outcomes

  1. double delta QTcF

    Time frame: up to 24 hours

    12 point of ECG measurements according to the interventions

Secondary outcomes

  1. double delta QTcI, double delta QTcSS

    Time frame: up to 24 hours

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jun 12, 2013
Registry last updated
Jun 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.