Blood Naloxone Levels Following Intradermal Injection in Humans
NCT05876572 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2024-11-01
Summary
The main purpose of this study is to evaluate pharmacokinetics/pharmacodynamics of intradermal administration of naloxone in healthy adult subjects.
Conditions
Interventions
- DRUG
-
intradermal naloxone
One time 8 mg/0.1 mL dose of naloxone to be administered intradermally
- DEVICE
-
microneedle injection
Intradermal delivery of naloxone using microneedle
Sponsors & Collaborators
-
DEKA S.r.l.
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Kathryn Rosenblatt, MD · Johns Hopkins University
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-08-31
- Primary Completion
- 2024-12-31
- Completion
- 2024-12-31
- FDA Drug
- Yes
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