The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) manufactured at the Totowa, NJ facility relative to the formulation (10 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
55
Reformulated OXY 10-mg tablet (Totowa) x 1 dose taken in the fasted state.
Reformulated OXY 10-mg tablet (Wilson) x 1 dose taken in the fasted state.
Covance Clinical Research Unit Madison
Madison, Wisconsin, 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 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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