This was a single-dose, randomized, double-blind, placebo-controlled, 3 way crossover study designed to evaluate the relative abuse potential of crushed EMBEDA® compared to morphine sulfate CR tablets and placebo in healthy male and female, non-dependent, recreational opioid users. An appropriate dose of morphine sulfate CR (i.e., 30 mg, 60 or 90 mg) was to be selected during Part A of the study (Dose Selection Phase). Each subject participated in the study for up to (approximately) 16 weeks and was confined in the clinic for a total of up to 12 nights.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
33
Lactose (100 mg) placebo tablets crushed; single dose
EMBEDA (morphine sulfate/naltrexone hydrochloride) 30 mg/ 1.2 mg extended release; capsule contents crushed; single dose
Morphine sulfate controlled release 30 mg tablet crushed
Drug Liking Visual Analog Scale maximum peak effect (Emax)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Drug Liking Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
High Visual Analog Scale maximum peak effect (Emax)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
High Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Drug Liking Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Drug Liking Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Drug Liking Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Drug Liking Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Drug Liking Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Drug Liking Visual Analog Scale Area time to maximum effect (TEmax)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
High VVisual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
High Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
High Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
High Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
High Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
High Visual Analog Scale Area time to maximum effect (TEmax)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Any Drug Effects Visual Analog Scale maximum peak effect (Emax)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Any Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Any Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Any Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Any Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Any Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Any Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Any Drug Effects Visual Analog Scale Area time to maximum effect (TEmax)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Good Drug Effects Visual Analog Scale maximum peak effect (Emax)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Good Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Good Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Good Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Good Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Good Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Good Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Good Drug Effects Visual Analog Scale Area time to maximum effect (TEmax)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Bad Drug Effects Visual Analog Scale maximum peak effect (Emax)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Bad Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Bad Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Bad Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Bad Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Bad Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Bad Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Bad Drug Effects Visual Analog Scale Area time to maximum effect (TEmax)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Feel Sick Visual Analog Scale maximum peak effect (Emax)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Feel Sick Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Feel Sick Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Feel Sick Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Feel Sick Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Feel Sick Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Feel Sick Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Feel Sick Visual Analog Scale Area time to maximum effect (TEmax)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Nausea Visual Analog Scale maximum peak effect (Emax)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Nausea Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Nausea Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Nausea Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Nausea Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Nausea Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Nausea Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Nausea Visual Analog Scale Area time to maximum effect (TEmax)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Sleepy Visual Analog Scale maximum peak effect (Emax)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Sleepy Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Sleepy Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Sleepy Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Sleepy Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Sleepy Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Sleepy Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Sleepy Visual Analog Scale Area time to maximum effect (TEmax)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Dizzy Visual Analog Scale maximum peak effect (Emax)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Dizzy Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Dizzy Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Dizzy Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Dizzy Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Dizzy Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Dizzy Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Dizzy Visual Analog Scale Area time to maximum effect (TEmax)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Pupil Diameter minimum peak effect (Emin)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Pupil Diameter time to minimum peak effect (TEmin)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Pupil Diameter Area under the effect curve to 1 hour (AUE0-1h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Pupil Diameter Area under the effect curve to 2 hours (AUE0-2h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Pupil Diameter Area under the effect curve to 4 hours (AUE0-4h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Pupil Diameter Area under the effect curve to 8 hours (AUE0-8h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Pupil Diameter Area under the effect curve to 12 hours (AUE0-12h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Pupil Diameter Area under the effect curve to 24 hours (AUE0-24h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Take Drug Again Visual Analog Scale maximum peak effect (Emax)
Time frame: 12 and 24 hours post dose
Take Drug Again Visual Analog Scale mean (Emean)
Time frame: 12 and 24 hours post dose
Overall Drug Liking Visual Analog Scale maximum peak effect (Emax)
Time frame: 12 and 24 hours post dose
Overall Drug Liking Visual Analog Scale mean (Emean)
Time frame: 12 and 24 hours post dose
Subject Rating Scale - Need to Blow Nose maximum peak effect (Emax)
Time frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Need to Blow Nose Area under the effect curve to 1 hour (AUE0-1h)
Time frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Need to Blow Nose Area under the effect curve to 2 hours (AUE0-2h)
Time frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Runny Nose/Nasal Discharge maximum peak effect (Emax)
Time frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Runny Nose/Nasal Discharge Area under the effect curve to 1 hour (AUE0-1h)
Time frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Runny Nose/Nasal Discharge Area under the effect curve to 2 hours (AUE0-2h)
Time frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Burning maximum peak effect (Emax)
Time frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Burning Area under the effect curve to 1 hour (AUE0-1h)
Time frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Burning Area under the effect curve to 2 hours (AUE0-2h)
Time frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Facial Pain/Pressure maximum peak effect (Emax)
Time frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Facial Pain/Pressure Area under the effect curve to 1 hour (AUE0-1h)
Time frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Facial Pain/Pressure Area under the effect curve to 2 hours (AUE0-2h)
Time frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Nasal Congestion maximum peak effect (Emax)
Time frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Nasal Congestion Area under the effect curve to 1 hour (AUE0-1h)
Time frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Nasal Congestion Area under the effect curve to 2 hours (AUE0-2h)
Time frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Plasma morphine - Maximum observed plasma concentration (Cmax)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma morphine - Time to maximum observed plasma concentration (Tmax)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma morphine - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma morphine - Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma morphine - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma 6-ß-naltrexol - Maximum observed plasma concentration (Cmax)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma 6-ß-naltrexol - Time to maximum observed plasma concentration (Tmax
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma 6-ß-naltrexol- Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma 6-ß-naltrexol- Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma morphine - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma morphine - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma morphine - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma morphine - Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma naltrexone - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma naltrexone - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma naltrexone - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma naltrexone - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma naltrexone - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma naltrexone - Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma naltrexone - Maximum observed plasma concentration (Cmax)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma naltrexone - Time to maximum observed plasma concentration (Tmax)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma naltrexone- Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
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