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This study was a single-center positive-controlled, randomized, dose-escalation study of HSK3486 in healthy female subjects administered as a single IV bolus dose.Subjects were confined to the study unit from the evening of Day -1 until the morning of Day 2, then were required to return for a follow up visit on Day 5. Intensive safety, PD and PK assessments were performed prior to dosing on Day 1 until 24 hours post-dose (Day 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK3486 | Experimental | 0.288 mg/kg ,0.432 mg/kg ,0.540 mg/kg ,0.648 mg/kg,0.810 mg/kg There were five cohorts of six subjects per cohort (5 HSK3486:1 propofol). |
|
| Propofol | Active Comparator | 2.5 mg propofol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK3486 | Drug | HSK3486 was administered as a single dose over a 1 minute infusion period. There were five cohorts of six subjects per cohort (5 HSK3486:1 propofol). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety by measurement of Adverse Events | First dose of study drug on day 1 | |
| Bispectral index (BIS) | From first dose of study drug until fully alert on day 1 | |
| Modified observer's assessment of alertness/sedation(MOAA/S) | Observe the change of modified observer's assessment of alert /sedation during the whole trial | Time Frame: From first dose of study drug until fully alert on day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C000730813 | HSK3486 |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Propofol | Drug | Propofol, at a dose of 2.5 mg/kg, was administered as a 1 minute infusion at a constant rate via infusion pump. |
|
| Time to plasma peak concentration(Tmax) |
| 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 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |