The purpose of this study is to evaluate the Pharmacokinetics/Pharmacodynamics and safety of Remimazolam Tosylate in healthy volunteers after loading/maintenance dose regimen.
1. Study the Pharmacokinetics/Pharmacodynamics of Remimazolam Tosylate in healthy volunteers after loading/maintenance dose regimen. 2. Study the reversal effect and time required of Flumazepine on Rimazolam'effect. 3. Study the Safety of Remimazolam Tosylate in healthy volunteers after loading/maintenance dose regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
8
Initial dose plus supplemental doses
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peak Plasma Concentration (Cmax) of Remimazolam in human plasma.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: From prior to study drug injection until 4 hours post-dose
Safety by measurement of Adverse Events.
Time frame: From start of study drug injection to patient discharge (approx. 2 days)
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