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Study to investigate the effect of BI 1744 CL on the QT/QTc interval of the ECG (electrocardiogram) in comparison to placebo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1744 CL | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Moxifloxacin (Avalox®) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1744 CL solution for inhalation | Drug |
| ||
| Placebo matching BI 1744 CL |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the mean time-matched QTcI (QT interval, individually corrected according to the factor estimated from each subject) | Baseline (day -1) and 20 to 120 min. after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the QTcI at different point | Baseline (day -1) and 10 min. to 8 hours after drug administration | |
| The mean of the QTcI values of all ECGs for Moxifloxacin and Placebo | 1 to 4 hours after drug administration |
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Inclusion Criteria:
All participants in the study will be healthy males or females, ranging from 21 to 50 years of age, with a body mass index (BMI) be within 18.5 to 29.9 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters). In accordance with Good Clinical Practice and the local legislation all volunteers will have given their written informed consent prior to admission to the study
Exclusion Criteria:
For Female Subjects:
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| ID | Term |
|---|---|
| D012996 | Solutions |
| D001239 | Inhalation |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
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| Drug |
|
| Moxifloxacin (Avalox®) | Drug |
|
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |