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The objective of the study is to assess that pramipexole does not prolong the QT interval more than placebo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pramipexole | Experimental |
| |
| Moxifloxacin | Active Comparator |
| |
| Pramipexole Placebo | Placebo Comparator |
| |
| Moxifloxacin Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pramipexole extended-release (ER) tablets | Drug |
| ||
| Pramipexole immediate-release (IR) tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Mean of the individually heart rate corrected QT interval (QTcI) values | 1 to 4 hours after dosing on day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean of the QTcI values | 1 to 4 hours after dosing at day 12 | |
| QTcI at any point in time | between 1 and 7 hours after dosing at day 12 and day 21 |
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Inclusion Criteria:
Exclusion Criteria:
For Female Subjects:
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| ID | Term |
|---|---|
| D013607 | Tablets |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
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| Drug |
|
| Moxifloxacin | Drug |
|
| Pramipexole Placebo | Drug |
|
| Moxifloxacin Placebo | Drug |
|
| D015363 |
| Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |