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

NCT03329014 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-04-04

No results posted yet for this study

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

Conditions

  • Procedural Sedation

Interventions

DRUG

Remimazolam

For induction and maintenance of sedation

DRUG

Placebo

Control arm

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Paion UK Ltd.

    lead INDUSTRY

Principal Investigators

  • Shawn Searly, M.D · PRA Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-15
Primary Completion
2017-06-09
Completion
2017-06-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03329014 on ClinicalTrials.gov