Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy Subjects

• Status: Unknown status
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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