Status:
UNKNOWN
Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy Subjects
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Sedation
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
The aim of this study is to investigate the safety, pharmacokinetics, pharmacodynamics of intranasal dexmedetomidine, and comparative pharmacokinetics of intranasally and intravenously administered de...
Eligibility Criteria
Inclusion
- Healthy adult male 18 - 40 years of age
- Body weight \>/= 50 kg (male) or \>/= 45 kg (female), with BMI between 19.0 and 26.0 kg/m2, inclusive
- Capable of giving written informed consent
Exclusion
- Clinically significant disease or conditions that may place the subject at unacceptable risk as a participant in the study, or that may interfere with the safety, tolerability or pharmacodynamic evaluations in the study
- Laboratory tests positive for HIV, Hepatitis B virus surface antigen, or Hepatitis C virus antibody; positive drug or alcohol test
- Major surgery within 4 weeks of screening
Key Trial Info
Start Date :
July 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2018
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03293277
Start Date
July 26 2017
End Date
July 1 2018
Last Update
January 23 2018
Active Locations (1)
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1
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China