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| Name | Class |
|---|---|
| The First Hospital of Jilin University | OTHER |
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It is a single-center, open-label, dose-finding, Phase I clinical study evaluating the pharmacokinetics, pharmacodynamics, and safety characteristics of HSK3486 in healthy elderly subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elderly groupⅠ | Active Comparator | Elderly groupⅠ 65 years or older 0.2 mg/kg HSK3486 |
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| Elderly group Ⅱ | Active Comparator | Elderly group Ⅱ 65 years or older 0.3 mg/kg HSK3486 |
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| Elderly group Ⅲ | Active Comparator | Elderly group Ⅲ 65 years or older 0.4 mg/kg HSK3486 |
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| Non-elderly group IV | Active Comparator | Non-elderly group IV 18 to 64 years 0.4 mg/kg HSK3486 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK3486 | Drug | Intravenously infuse 0.2 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min. |
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| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration (Cmax) | Cmax(a measure of the body's exposure to HSK3486)will be compared between non-elderly subjects and elderly subjects. | -30 minutes before administration until 24 hours post administration on day 1 |
| Area under the concentration-time curve(AUC) | AUC(a measure of the body's exposure to HSK3486)will be compared between non-elderly subjects and elderly subjects. | -30 minutes before administration until 24 hours post administration on day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| MOAA/S(modified observer's assessment of alert /sedation) | modified observer's assessment of alert /sedation | -5 minutes before administration until 1 hours post administration on day 1 |
| Bispectral index(BIS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanhua Ding, PhD | Phase I Clinical Trial Laboratory,The First Hospital of Jilin University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phase I Clinical Trial Laboratory, The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28430430 | Result | Qin L, Ren L, Wan S, Liu G, Luo X, Liu Z, Li F, Yu Y, Liu J, Wei Y. Design, Synthesis, and Evaluation of Novel 2,6-Disubstituted Phenol Derivatives as General Anesthetics. J Med Chem. 2017 May 11;60(9):3606-3617. doi: 10.1021/acs.jmedchem.7b00254. Epub 2017 Apr 28. |
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| ID | Term |
|---|---|
| C000730813 | HSK3486 |
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| HSK3486 | Drug | Intravenously infuse 0.3 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min. |
|
|
| HSK3486 | Drug | Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min. |
|
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| HSK3486 | Drug | Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min. |
|
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Bispectral index
| -5 minutes before administration until 1 hours post administration on day 1 |
| Tmax | time to peak observed | -30 minutes before administration until 24 hours post administration on day 1 |
| Total clearance | Total clearance | -30 minutes before administration until 24 hours post administration on day 1 |
| blood pressure(systolic, diastolic and mean arterial pressure) | safety endpoits | from the screening to 2 days post-dose |