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NCT03293277 Clinical Trial

Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy Subjects

Sedation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03293277
Other study ID # HR0171401-101
Secondary ID
Status Recruiting
Phase Phase 1
First received August 23, 2017
Last updated January 18, 2018
Start date July 26, 2017
Est. completion date July 2018

Study information
Verified date January 2018
Source Jiangsu HengRui Medicine Co., Ltd.
Contact Shirley Cai, MD
Phone 18036618138
Email caixiaoli@shhrp.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 48
Est. completion date July 2018
Est. primary completion date July 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Intranasal Dexmedetomidine
Intranasal Dexmedetomidine
• Intravenous Dexmedetomidine
Intravenous Dexmedetomidine
• Intranasal Placebo
Intranasal Placebo
• Intravenous Placebo
Intravenous Placebo

Locations
Country Name City State
China The Third Xiangya Hospital of Central South University Changsha Hunan

Sponsors (1)
Lead Sponsor Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Events Number of subjects with adverse events Baseline to 7 days after dose administration
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