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

Procedural Sedation Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled 9-period Crossover, Dose-Escalation Study on the Safety, Bioavailability and Pharmacodynamics of Remimazolam Administered Intranasally as Powder and as Solution in Healthy Subjects

Clinical Trial 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

Clinical Trial Description

The design will be a randomized, double-blind, comparative, placebo- and active-controlled nine-period crossover study in healthy male volunteers. Subjects will be randomized and will receive each of the 9 treatments which will be separated by a minimum of 48 hours.The first treatment arm will always be the intravenous remimazolam. Eligible subjects will then be randomized to treatment sequence prior to study drug administration in treatment period 2. Each subject will participate in the study for up to 51 days, from Screening until Follow-up. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03329014
Study type Interventional
Source Paion UK Ltd.
Contact
Status Completed
Phase Phase 1
Start date May 15, 2017
Completion date June 14, 2017
View Details
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