The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (40 mg) relative to the original OxyContin® (OXY) formulation (40 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
92
Reformulated OXY 40-mg tablet x 1 dose taken without food
Original OxyContin® (OXY) 40-mg tablet x 1 dose taken without food
Covance Clinical Research Unit - Evansville
Evansville, Indiana, United States
Cmax - Maximum Observed Plasma Concentration
Bioequivalence based on Cmax
Time frame: Blood samples collected over 72-hour period
AUC0-inf - Area Under the 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.