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ADASUVE-Lorazepam Drug-Drug Interaction

NCT01877642 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2017-12-13

Study results available
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Summary

This study will compare the safety and effects over time for giving both ADASUVE and lorazepam (intramuscular) compared to that of each agent given alone.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Lorazepam 1 mg IM

Lorazepam 1 mg intramuscular

DRUG

Inhaled loxapine 10 mg

Inhaled Staccato loxapine 10 mg

DRUG

Inhaled Placebo

Inhaler with no drug in it to mimic the ADASUVE inhaler

DRUG

Placebo IM

intramuscular placebo to mimic lorazepam 1 mg IM

Sponsors & Collaborators

  • Alexza Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Randall R Stoltz, MD · Medical Director, Covance-Evansville, Evansville, IN 47710

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2013-07-31
Completion
2013-07-31
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 NCT01877642 on ClinicalTrials.gov