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drugset / Trial / NCT03329014

A Trial of Intranasal Remimazolam Pharmacokinetics, Pharmacodynamics, Safety and Bioavailability

NCT03329014 ↗

Phase 1 Completed 12 enrolled Paion UK Ltd. PRA Health Sciences · collab
RandomizedCrossoverQuadruple-blindTreatment

Summary

A prospective dose escalation, nine period cross-over trial assessing the safety, pharmacokinetics, bioavailability and pharmacodynamics of escalating doses of Remimazolam when administered intranasally as powder and solution in healthy subjects and compared to an intravenous control

Timeline

Start
2017-05-15
Primary completion
2017-06-09
Completion
2017-06-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Remimazolam Small molecule 4 mg Intravenous
Subject Remimazolam Small molecule 10 mg Intravenous
Subject Remimazolam Small molecule 20 mg Intravenous
Subject Remimazolam Small molecule 40 mg Intravenous

Indications

No indication recorded.