A Randomized, double-blind, placebo-controlled, two-way crossover trial to compare Moxifloxacin induced QT interval prolongation in Japanese and Korean healthy subjects

Not Applicable

Recruiting

• Conditions: Healthy subjects

• Registration Number: JPRN-UMIN000009117
• Lead Sponsor: Clinical trial Center,Kitasato University East Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

1.Medical History and Concurrent Diseases 1)Any significant acute or chronic medical illness. 2)Subject with clinically significant hepatic disorder 3)History of epilepsy 4)History of hypoglycemia 5)Any gastrointestinal surgery that could impact upon the absorption of study drug. 6)Donation of blood Less than 200ml within 30days prior to study drug administration more than 200ml Within 90 days prior to study drug administration 7)Smoking more than 10 cigarettes per day. 8)Any major surgery within 4 weeks prior to study drug administration. 9)Received any investigational drug within 120 days prior to study drug administration 10)Any other sound medical, psychiatric and/or social reason as determined by the investigators. 2.Physical and Laboratory Test Findings 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. -HR<45 bpm or HR>100 bpm -PR=<210 msec -QRS=<120 msec -QT=<500 msec -QTcF: male=<450 msec, female=<470msec -IRBBB -Marked Sinus Arrhythmia -Wondering pacemaker -Atrial rhythm 3)Positive urine screen for drugs of abuse. 4)Positive alcohol breath test 5)Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, HIV-1, -2 antibody or serological reaction of syphilis. 3.Allergies and Adverse Drug Reaction 1)History of severe allergic disease. 2)History of allergy or intolerance moxifloxacin or any member of the quinolone drug class. 3)History of any significant drug allergy (such as anaphylaxis or hepatotoxicity). 4.Other Exclusion Criteria and so on

Study & Design

• Study Type: Interventional
• Study Design: Not specified