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

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Inje University
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

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