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

Inje University

Status

Completed

Conditions

Healthy

Treatments

Drug: Placebo

Drug: Moxifloxacin

Study type

Interventional

Funder types

Other

Identifiers

NCT01876316

12-166

Details and patient eligibility

About

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

Full 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.

Enrollment

40 patients

Sex

All

Ages

20 to 35 years old

Volunteers

Accepts Healthy Volunteers

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.
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