Relative Bioavailability Study of an Abuse-Deterrent Formulation of Extended-Release Oxycodone with Sequestered Naltrexone (ALO-02) Versus Immediate-Release Oxycodone Tablets in Healthy Volunteers

Abbreviations: AE: Adverse Event; ALT: Alanine Aminotransferase; AUCinf: Area Under the Plasma Concentration-Time Profile from Time 0 to Infinity; AUClast: Area Under the Curve to the Last Quantifiable Concentration; BLQ: Below Lower Limit of Quantification; BMI: Body Mass Index; BP: Blood Pressure; C24: Concentration at 24 Hours Post Dose; Clast*: the Predicted Plasma Concentration at the Last Quantifiable Time Point Estimated from the Log-Linear Regression Analysis; Cmax: Maximum Plasma Concentration; CI: Confidence Interval; CRU: Clinical Research Unit; CV: Coefficient of Variation; dn: Dose-Normalized to 1 mg; ECG: Electrocardiogram; ER: Extended Release; FDA: US Food and Drug Administration; GGT: Gamma-Glutamyl Transferase; IR: Immediate Release; IRO: Immediate-Release Oxycodone; kel: the Terminal Phase Rate Constant; PK: Pharmacokinetic; QC: Quality Control; RE: Relative Error; t1/2: Terminal Half-Life; Tmax: Time to Maximum Plasma Concentration; ULN: Upper Limit of Normal; US: United States