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A Study to Assess the Time to Onset of Action of Staccato Alprazolam Versus Midazolam and Diazepam in Healthy Participants

NCT07020988 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2026-02-20

No results posted yet for this study

Summary

The purpose of this study is to estimate the difference in the time to onset of action between Staccato alprazolam and intravenous (iv) midazolam using changes in power in the combined spindle and β1 frequency bands in the qEEG (quantitative electroencephalogram).

Conditions

  • Healthy Participants

Interventions

DRUG

Staccato Alprazolam

Study participants will receive single dose of Staccato Alprazolam at pre-specified time points.

DRUG

Midazolam

Study participants will receive single dose of IV Midazolam at pre-specified time points.

DRUG

Diazepam

Study participants will receive single dose of Nasal Diazepam by inhalation at pre-specified time points.

Sponsors & Collaborators

  • UCB Biopharma SRL

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-12
Primary Completion
2026-01-06
Completion
2026-01-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT07020988 on ClinicalTrials.gov