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Study of Midazolam in Healthy Adults

NCT04679623 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-03-17

No results posted yet for this study

Summary

This study is a phase 1, open-label, crossover, comparison study to evaluate the safety and pharmacokinetics (PK) of a single IM administration of 10 mg midazolam using Rafa's auto-injector compared with seizalam in healthy adults. All subjects will participate in both study periods which will span 28 days following a pre study screening visit.

Conditions

  • Status Epilepticus

Interventions

COMBINATION_PRODUCT

Midazolam

Midazolam Injection, 10mg

DRUG

Seizalam

Seizalam, 10 mg

Sponsors & Collaborators

  • Alachua Government Services, Inc.

    collaborator INDUSTRY

  • Joint Project Management Office for Chemical, Biological, Radiological, and Nuclear Medical

    collaborator UNKNOWN

  • Rafa Laboratories

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-06-09
Primary Completion
2021-09-17
Completion
2021-09-17
FDA Drug
Yes
FDA Device
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 NCT04679623 on ClinicalTrials.gov