To determine the pharmacokinetics of 2 intranasal doses and 1 oral dose of naltrexone compared to an intramuscular dose of naltrexone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Vince and Associates Clinical Research, Inc.
Overland Park, Kansas, United States
Plasma Concentration (Cmax)
Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration
Time frame: 48 hours
Plasma Concentration (Tmax)
Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration
Time frame: 48 hours
Plasma Concentration (AUC 0-t)
Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration
Time frame: 48 hours
Plasma Concentration (AUC 0-inf)
Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration
Time frame: 48 hours
Adverse Events
Will be reported from the start of the first session to follow-up visit
Time frame: Maximum of 18 days
Vital Signs
Measured before and after naltrexone administration
Time frame: 12 days
12-lead electrocardiogram
Measured before and after naltrexone administration
Time frame: 12 days
Nasal Irritation Scoring
Will be reported from the start of the first session to follow-up visit
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Time frame: 5 days