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