A Phase I Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- Intranasal Placebo
- Conditions
- Sedation
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Adverse Events
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
C
80µg Dexmedetomidine or Placebo is administered intranasally on Day 1
Intervention: Intranasal Placebo
A2
20µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intranasally on Day 8
Intervention: Intranasal Placebo
A1
20µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intravenousally on Day 8
Intervention: Intranasal Dexmedetomidine
A1
20µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intravenousally on Day 8
Intervention: Intravenous Dexmedetomidine
C
80µg Dexmedetomidine or Placebo is administered intranasally on Day 1
Intervention: Intranasal Dexmedetomidine
A1
20µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intravenousally on Day 8
Intervention: Intranasal Placebo
A1
20µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intravenousally on Day 8
Intervention: Intravenous Placebo
A2
20µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intranasally on Day 8
Intervention: Intranasal Dexmedetomidine
A2
20µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intranasally on Day 8
Intervention: Intravenous Dexmedetomidine
A2
20µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intranasally on Day 8
Intervention: Intravenous Placebo
B1
40µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intravenousally on Day 8
Intervention: Intranasal Dexmedetomidine
B1
40µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intravenousally on Day 8
Intervention: Intravenous Dexmedetomidine
B1
40µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intravenousally on Day 8
Intervention: Intranasal Placebo
B1
40µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intravenousally on Day 8
Intervention: Intravenous Placebo
B2
40µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intranasally on Day 8
Intervention: Intranasal Dexmedetomidine
B2
40µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intranasally on Day 8
Intervention: Intravenous Dexmedetomidine
B2
40µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intranasally on Day 8
Intervention: Intranasal Placebo
B2
40µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intranasally on Day 8
Intervention: Intravenous Placebo
Outcomes
Primary Outcomes
Adverse Events
Time Frame: Baseline to 7 days after dose administration
Number of subjects with adverse events