The purpose of this study is to estimate the effects of food and of sprinkling ALO-02 pellets on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol from an extended release pellets-in-capsule formulation of oxycodone 40 mg with sequestered naltrexone 4.8 mg.
Bioavailability
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
single dose of ALO-02 capsule under fasting condition
single dose of ALO-02 capsule under fed condition
ALO-02 with the ALO-02 pellets sprinkled on applesauce, and administered under fasting conditions.
Pfizer Investigational Site
New Haven, Connecticut, United States
Area Under the Curve (AUC) to time infinity (inf) of oxycodone
Time frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
Area Under the Curve (AUC) to last quantifiable concentration (last) of oxycodone
Time frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
Maximum Plasma Concentration (Cmax) of oxycodone
Time frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
C24, Tmax (time at maximum concentration) and half-life of oxycodone, as data permit.
Time frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
AUClast, AUCinf, and Cmax of naltrexone and 6-beta-naltrexol, as data permit
Time frame: predose, 1,2,4,8,12,24,48,120 hours post-dose
Adverse events, vital signs, pulse oximetry, and safety laboratory parameters.
Time frame: over 120 hours
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