Healthy
Conditions
Keywords
Moxifloxacin, QT interval prolongation, Korean, Japanese
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.
Interventions
DRUGMoxifloxacin
single oral administration of 400mg of moxifloxacin
DRUGPlacebo
single oral administration of 400mg of placebo
Sponsors
Inje University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| double delta QTcF | up to 24 hours | 12 point of ECG measurements according to the interventions |
Secondary
| Measure | Time frame |
|---|---|
| double delta QTcI, double delta QTcSS | up to 24 hours |
Outcome results
None listed