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The purpose of this study is to evaluate and compare the Pharmacokinetics/Pharmacodynamics and safety of Remimazolam Tosylate with midazolam in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.Remimazolam Tosylate | Experimental | Single IV bolus of Remimazolam Tosylate over 1 minute at 0.01 mg/kg body weight |
|
| 2.Remimazolam Tosylate | Experimental | Single IV bolus of Remimazolam Tosylate over 1 minute at 0.02 mg/kg body weight |
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| 3.Remimazolam Tosylate | Experimental | Single IV bolus of Remimazolam Tosylate over 1 minute at 0.05 mg/kg body weight |
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| 4.Remimazolam Tosylate | Experimental | Single IV bolus of Remimazolam Tosylate over 1 minute at 0.075 mg/kg body weight |
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| 5.Remimazolam Tosylate | Experimental | Single IV bolus of Remimazolam Tosylate over 1 minute at 0.1 mg/kg body weight |
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| 6.Remimazolam Tosylate | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam Tosylate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To study the Pharmacokinetics of Remimazolam Tosylate by assessment of drug concentration through blood sample analysis | Pre-dose to 8 hours post-dosee | |
| Bispectral index (BIS) and Modified Observer's Assessment of Alertness/Sedation(MOAA/S) score assessments | Pre-dose to 2 hours post-dose | |
| Adverse eventï¼›Vital signï¼›Physical examinationï¼›Laboratory examinationï¼›ECGï¼›The nervous system function test | Pre-dose to 24 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bei Hu, Professor | Peiking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | 100032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32178858 | Derived | Chen X, Sang N, Song K, Zhong W, Wang H, Jiang J, Huang Y, Hu P. Psychomotor Recovery Following Remimazolam-induced Sedation and the Effectiveness of Flumazenil as an Antidote. Clin Ther. 2020 Apr;42(4):614-624. doi: 10.1016/j.clinthera.2020.02.006. Epub 2020 Mar 13. | |
| 30510509 | Derived | Zhou Y, Hu P, Huang Y, Nuoer S, Song K, Wang H, Wen J, Jiang J, Chen X. Population Pharmacokinetic/Pharmacodynamic Model-Guided Dosing Optimization of a Novel Sedative HR7056 in Chinese Healthy Subjects. Front Pharmacol. 2018 Nov 19;9:1316. doi: 10.3389/fphar.2018.01316. eCollection 2018. |
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| ID | Term |
|---|---|
| C573194 | 4-methylbenzenesulfonic acid |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Single IV bolus of Remimazolam Tosylate over 1 minute at 0.15 mg/kg body weight |
|
| 7.Remimazolam Tosylate | Experimental | Single IV bolus of Remimazolam Tosylate over 1 minute at 0.2 mg/kg body weight |
|
| 8.Remimazolam Tosylate | Experimental | Single IV bolus of Remimazolam Tosylate over 1 minute at 0.25 mg/kg body weight |
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| 9.Remimazolam Tosylate | Experimental | Single IV bolus of Remimazolam Tosylate over 1 minute at 0.3mg/kg body weight |
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| 10.Remimazolam Tosylate | Experimental | Single IV bolus of Remimazolam Tosylate over 1 minute at 0.35 mg/kg body weight |
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| 11.Midazolam | Active Comparator | Single IV bolus of Midazolam over 1 minute at 0.075 mg/kg body weight |
|
| Midazolam | Drug |
|
| D006571 | Heterocyclic Compounds |