Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers
Completed · Phase 1
Conditions studied: Drug Overdose, Opioid-Related Disorders
In brief
To determine the pharmacokinetics of 4 intranasal doses of naloxone compared to a 0.4 mg dose of naloxone administrated intramuscular and to identify an appropriate intranasal dose that could achieve systemic exposure comparable to an approved parenteral dose. To also determine the pharmacokinetics of two different concentrations of intranasal naloxone and finally, to determine the safety of intranasal naloxone with respect to nasal irritation.
Key facts
- Study ID
- NCT02572089
- Run by
- National Institute on Drug Abuse (NIDA)
- People needed
- 30
- Starts
- 2014-10-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2017-01-12
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Be able to provide written consent
- Must have a BMI ranging from 18 to 30kg/m2, inclusive
- Must have adequate venous access
- Must not have any clinically significant concurrent medical conditions determine by medical history, physical examination, vital signs, and 12-lead electrocardiogram.
- Must agree to use a reliable double-barrier method of birth control from the start of screening until one week after completing the study. Oral contraceptives are prohibited.
- Must agree to not ingest alcohol, drinks containing xanthine greater than 500 mg/day (e.g., Coca Cola, coffee, tea, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study.
You may not qualify if…
- Please contact clinical site directly for more information
Where it is running
- Vince Associates Clinical Research — Overland Park, Kansas, United States
Full record on ClinicalTrials.gov
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