Healthy subjects
Conditions
Interventions
Moxifloxacin
Placebo
Sponsors
Clinical trial Center,Kitasato University East Hospital
Inje University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed Written Informed Consent 1) The signed informed consent form 2. Target Population 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. 3. Age, Sex, and Reproductive Status 1) Male and female, ages 20 to 35 years inclusive. 2) Female must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 48 hours prior to the start of investigational product. 3) Female must not be breastfeeding.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| QT prolongation of Moxifloxacin | — |
Secondary
| Measure | Time frame |
|---|---|
| safety | — |
Countries
Japan,Asia(except Japan)
Outcome results
None listed