The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured at the Wilson, NC facility 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
58
Reformulated OXY 80-mg tablet (Totowa) x 1 dose taken without food.
Reformulated OXY 80-mg tablet (Wilson) x 1 dose taken without food.
Covance Clinical Research Unit Honolulu
Honolulu, Hawaii, United States
Cmax - Maximum Observed Plasma Concentration
Bioequivalence based on Cmax
Time frame: Blood samples collected over 72-hour period
AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Bioequivalence 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
Bioequivalence based on AUC0-t
Time frame: Blood samples collected over 72-hour period
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