NCT03293277

Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy Subjects

A Phase I Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Intranasal Dexmedetomidine	Intranasal Dexmedetomidine
DRUG	Intravenous Dexmedetomidine	Intravenous Dexmedetomidine
DRUG	Intranasal Placebo	Intranasal Placebo
DRUG	Intravenous Placebo	Intravenous Placebo

Timeline

• Start date: 2017-07-26
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2017-09-26
• Last updated: 2018-01-23

Locations

1 site across 1 country: China