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This study was a single center, open-label, single dose escalation study in healthy male subjects to investigate a bolus dose followed by a 30 minute constant infusion of HSK3486 over two cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK3486 | Experimental | 0.288 mg/kg bolus (1 min)+ 1 mg/kg/h constant infusion (30 min) or 0.540 mg/kg bolus (1 min)+ 2 mg/kg/h constant infusion (30 min) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK3486 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety by measurement of Adverse Events | First dose of study drug on day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Modified observer's assessment of alertness/sedation(MOAA/S) | Observe the change of modified observer's assessment of alert /sedation during the whole trial | From first dose of study drug until fully alert on day 1 |
| Bispectral index (BIS) |
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Inclusion Criteria:
Exclusion Criteria:
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Single Group Assignment
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| From first dose of study drug until fully alert on day 1 |
| Median effective dose (ED50) | From first dose of study drug until fully alert on day 1 |
| Peak concentration (Cmax) | From the start of administration to 48 hours after administration |
| Time to plasma peak concentration(Tmax) | From the start of administration to 48 hours after administration |
| Terminal elimination half life (t1/2z) and mean residence time (MRT) | From the start of administration to 48 hours after administration |
| Mean residence time (MRT) | From the start of administration to 48 hours after administration |
| Area Under the Curve (AUC0-30min, AUC0-1h, AUC0-last, and AUC0-inf) | From the start of administration to 48 hours after administration |
| Total clearance (CL) | From the start of administration to 48 hours after administration |
| ID | Term |
|---|---|
| C000730813 | HSK3486 |
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