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A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers

NCT01364558 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-11-01

Study results available
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Summary

The purpose of this clinical research study is to assess the bioavailability and pharmacokinetics of two formulations of diazepam after intranasal (nasal spray) and injectable diazepam after intravenous (I.V.) administration

Conditions

Interventions

DRUG

Diazepam

Diazepam will be administered as a 5 mg dose given IV. The two nasal formulations will be given as a 10 mg dose.

DRUG

Diazepam

IV diazepam will be given as a 5 mg dose. The two nasal formulations will be given as 10 mg doses.

Sponsors & Collaborators

Principal Investigators

  • James Cloyd, Pharm D. · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT01364558 on ClinicalTrials.gov