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The purpose of this study is to evaluate the Pharmacokinetics/Pharmacodynamics and safety of Remimazolam Tosylate in healthy volunteers after loading/maintenance dose regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam Tosylate 1 | Experimental | IV bolus of Remimazolam Tosylate with a loading dose of 0.4mg/kg body weight over 1 minute followed by a maintenance dose of 1.5mg/kg/h over 2 hours.1 h 55 min after dosing start, 0.5 mg Flumazenil is administered |
|
| Remimazolam Tosylate 2 | Experimental | IV bolus of Remimazolam Tosylate with a loading dose of 0.4mg/kg body weight over 1 minute followed by a maintenance dose of 1.5mg/kg/h over 2 hours.1 h 55 min after dosing start time,0.5ml placebo is administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam Tosylate | Drug | Initial dose plus supplemental doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of Remimazolam in human plasma. | From prior to study drug injection until 4 hours post-dose | |
| Area under the plasma concentration versus time curve (AUC) of Remimazolam in human plasma. | From prior to study drug injection until 4 hours post-dose | |
| Peak Plasma Concentration (Cmax) of M01 in human plasma. | M01 is the main metabolite of Remimazolam | From prior to study drug injection until 4 hours post-dose |
| Area under the plasma concentration versus time curve (AUC) of M01 in human plasma. | M01 is the main metabolite of Remimazolam | From prior to study drug injection until 4 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety by measurement of Adverse Events. | From start of study drug injection to patient discharge (approx. 2 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pei Hu | Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 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. |
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| ID | Term |
|---|---|
| C573194 | 4-methylbenzenesulfonic acid |
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