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Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy Subjects

NCT03293277 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-01-23

No results posted yet for this study

Summary

The aim of this study is to investigate the safety, pharmacokinetics, pharmacodynamics of intranasal dexmedetomidine, and comparative pharmacokinetics of intranasally and intravenously administered dexmedetomidine in healthy volunteers.

Conditions

  • Sedation

Interventions

DRUG

Intranasal Dexmedetomidine

Intranasal Dexmedetomidine

DRUG

Intravenous Dexmedetomidine

Intravenous Dexmedetomidine

DRUG

Intranasal Placebo

Intranasal Placebo

DRUG

Intravenous Placebo

Intravenous Placebo

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-07-26
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • China

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 NCT03293277 on ClinicalTrials.gov