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The aim of this study is to investigate the safety, pharmacokinetics, pharmacodynamics of intranasal dexmedetomidine, and comparative pharmacokinetics of intranasally and intravenously administered dexmedetomidine in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Experimental | 20µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intravenousally on Day 8 |
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| A2 | Experimental | 20µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intranasally on Day 8 |
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| B1 | Experimental | 40µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intravenousally on Day 8 |
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| B2 | Experimental | 40µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intranasally on Day 8 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal Dexmedetomidine | Drug | Intranasal Dexmedetomidine |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of subjects with adverse events | Baseline to 7 days after dose administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shirley Cai, MD | Contact | 18036618138 | caixiaoli@shhrp.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | China |
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| C |
| Experimental |
80µg Dexmedetomidine or Placebo is administered intranasally on Day 1 |
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| Intravenous Dexmedetomidine | Drug | Intravenous Dexmedetomidine |
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| Intranasal Placebo | Drug | Intranasal Placebo |
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| Intravenous Placebo | Drug | Intravenous Placebo |
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