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The primary objective of this trial is to compare the relative hemodynamic effect of a novel intravenous formulation of amiodarone (PM101), administered as an immediate IV bolus push, with placebo and with the currentlyl available formulation of Amiodarone IV, administered as a 10-minute IV infusion, on systolic arterial pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo Control |
|
| PM101 | Experimental | PM101 |
|
| Amiodarone IV | Active Comparator | Amiodarone IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amiodarone | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systolic blood pressure | 15 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000638 | Amiodarone |
| ID | Term |
|---|---|
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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