100
Participants
Start Date
March 31, 2012
Primary Completion Date
May 31, 2012
Study Completion Date
May 31, 2012
45-mg hydrocodone bitartrate extended-release tablet (crushed or intact)
"Phase B:~Eligible subjects will be randomized to treatment sequence XY or YX whereby treatment X is 60 mL of a noncarbonated flavored beverage and treatment Y is hydrocodone bitartrate powder at a dose strength of 45-mg reconstituted in 60 mL of a noncarbonated flavored beverage.~Phase C:~Eligible subjects will be randomly assigned to 1 of 4 treatment arms:~Treatment A: intact placebo tablet, 60 mL noncarbonated flavored beverage, 1 crushed 45-mg hydrocodone bitartrate extended-release tablet.~Treatment B: intact placebo tablet, hydrocodone bitartrate powder at a dose strength of 45-mg in 60 mL of a noncarbonated flavored beverage and 1 crushed placebo tablet.~Treatment C: intact 45-mg hydrocodone bitartrate extended-release tablet, 60 mL noncarbonated flavored beverage, and 1 crushed placebo tablet Treatment D: intact placebo tablet, 60 mL noncarbonated flavored beverage, and 1 crushed placebo tablet."
Placebo
Placebo will consist of 60 mL of a non-carbonated beverage without the addition of active treatment
Cephalon Investigational Site 001, Salt Lake City
Cephalon Investigational Site 100, Toronto
Lead Sponsor
Cephalon
INDUSTRY