Sedation
Conditions
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 dexmedetomidine in healthy volunteers.
Interventions
DRUGIntranasal Dexmedetomidine
Intranasal Dexmedetomidine
Intravenous Dexmedetomidine
DRUGIntranasal Placebo
Intranasal Placebo
DRUGIntravenous Placebo
Intravenous Placebo
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Baseline to 7 days after dose administration | Number of subjects with adverse events |
Countries
China
Contacts
Primary ContactShirley Cai, MD
Outcome results
None listed