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To assess the safety and tolerance of 5 mL to 20 mL PEG 400 in multiple rising doses
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG 400 | Experimental | multiple rising doses |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG 400 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with clinically relevant findings in vital signs | blood pressure, pulse rate | up to 7 days after last drug administration |
| Number of subjects with clinically relevant findings in laboratory tests | up to 7 days after last drug administration | |
| Number of subjects with clinically relevant findings in 12-lead ECG | up to 7 days after last drug administration | |
| Number of subjects with clinically relevant findings in physical examination | up to 7 days after last drug administration | |
| Number of subjects with adverse events | up to 7 days after last drug administration | |
| Assessment of global tolerability by the investigator on a 4-point rating scale | up to 7 days after last drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C000595213 | polyethylene glycol 400 |
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