- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03293277
Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy Subjects
January 18, 2018 updated by: Jiangsu HengRui Medicine Co., Ltd.
A Phase I Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy Subjects
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hunan
-
Changsha, Hunan, China
- Recruiting
- The Third Xiangya Hospital of Central South University
-
Contact:
- Jie Huang
- Phone Number: 15116469024
- Email: cellahuang1988@163.com
-
Principal Investigator:
- Guoping Yang, PhD
-
Principal Investigator:
- Wen Ouyang, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: A1
20µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intravenousally on Day 8
|
Intranasal Dexmedetomidine
Intravenous Dexmedetomidine
Intranasal Placebo
Intravenous Placebo
|
EXPERIMENTAL: A2
20µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intranasally on Day 8
|
Intranasal Dexmedetomidine
Intravenous Dexmedetomidine
Intranasal Placebo
Intravenous Placebo
|
EXPERIMENTAL: B1
40µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intravenousally on Day 8
|
Intranasal Dexmedetomidine
Intravenous Dexmedetomidine
Intranasal Placebo
Intravenous Placebo
|
EXPERIMENTAL: B2
40µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intranasally on Day 8
|
Intranasal Dexmedetomidine
Intravenous Dexmedetomidine
Intranasal Placebo
Intravenous Placebo
|
EXPERIMENTAL: C
80µg Dexmedetomidine or Placebo is administered intranasally on Day 1
|
Intranasal Dexmedetomidine
Intranasal Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: Baseline to 7 days after dose administration
|
Number of subjects with adverse events
|
Baseline to 7 days after dose administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 26, 2017
Primary Completion (ANTICIPATED)
July 1, 2018
Study Completion (ANTICIPATED)
July 1, 2018
Study Registration Dates
First Submitted
August 23, 2017
First Submitted That Met QC Criteria
September 24, 2017
First Posted (ACTUAL)
September 26, 2017
Study Record Updates
Last Update Posted (ACTUAL)
January 23, 2018
Last Update Submitted That Met QC Criteria
January 18, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- HR0171401-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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