The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fasted state.
Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
84
Reformulated OXY 80-mg tablet x 1 dose taken without food.
Original OxyContin® (OXY) 80-mg tablet x 1 dose taken without food.
Covance Clinical Research Unit Honolulu
Honolulu, Hawaii, United States
Cmax - Maximum Observed Plasma Concentration
Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax.
Time frame: Blood samples collected over a 72-hour period.
AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)
AUC0-inf is the area under the plasma concentration-time curve from time zero to infinity (extrapolated) and bioequivalence is based on AUC0-inf.
Time frame: Blood samples collected over 72-hour period
AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration
AUC0-t is the area under the plasma concentration-time curve from time zero to time of last non-zero plasma concentration and bioequivalence is based on AUC0-t.
Time frame: Blood samples collected over 72-hour period
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