A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers

• Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose. ] [ Designated as safety issue: No ]
• Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose. ] [ Designated as safety issue: No ]
• Area under the Concentration-Time Curve (AUC) [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose. ] [ Designated as safety issue: No ]
• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose. ] [ Designated as safety issue: No ]
• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose. ] [ Designated as safety issue: No ]

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Screening up to approximately 3 months ] [ Designated as safety issue: Yes ]
• Percentage of participants with treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Screening up to approximately 3 months ] [ Designated as safety issue: Yes ]
• Change from Baseline in Diastolic Blood Pressure at each Post-Dose Assessment [ Time Frame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose. ] [ Designated as safety issue: Yes ]
• Change from Baseline in Systolic Blood Pressure at each Post-Dose Assessment [ Time Frame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose. ] [ Designated as safety issue: Yes ]
• Change from Baseline to each Post-Dose Assessment in Heart Rate [ Time Frame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose. ] [ Designated as safety issue: Yes ]
• Change from Baseline to each Post-Dose Assessment in Respiratory Rate [ Time Frame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose. ] [ Designated as safety issue: Yes ]
• Change from Baseline to each Post-Dose Assessment in Pulse Oximetry (SpO2, %) [ Time Frame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose. ] [ Designated as safety issue: Yes ]
• Change from Screening to End-of-Study Assessment in Hematology Parameters [ Time Frame: Screening up to approximately 3 months ] [ Designated as safety issue: Yes ]
• Change from Screening to End-of-Study Assessment in Chemistry Parameters [ Time Frame: Screening up to approximately 3 months ] [ Designated as safety issue: Yes ]
• Change from Screening to End-of-Study Assessment in Urinalysis Parameters [ Time Frame: Screening up to approximately 3 months ] [ Designated as safety issue: Yes ]
• Change from Screening to End-of-Study Assessment in ECG Measurements [ Time Frame: Screening up to approximately 3 months ] [ Designated as safety issue: Yes ]

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Screening up to approximately 3 months ] [ Designated as safety issue: Yes ]
• Percentage of participants with treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Screening up to approximately 3 months ] [ Designated as safety issue: Yes ]

This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 5-dosing period study to characterize the pharmacokinetics (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the pharmacokinetics of oxycodone. The study will take place over approximately two and a half months and will consist of three phases: a screening visit to determine eligibility for the study, a 5-dosing period treatment phase, and an end-of-study visit.

• Analgesia
• Acute Pain
• Chronic Pain
• Narcotic Abuse
• Opioid-related Disorders

• Drug: oxycodone hydrochloride
  oxycodone hydrochloride 5 mg tablet under fasted conditions
• Drug: oxycodone hydrochloride
  2 x oxycodone hydrochloride 5 mg tablets under fasted conditions
• Drug: oxycodone hydrochloride
  2 x oxycodone hydrochloride 7.5 mg tablets under fasted conditions
• Drug: oxycodone hydrochloride
  2 x oxycodone hydrochloride 7.5 mg tablets under fed conditions
• Drug: marketed oxycodone hydrochloride
  1 x oxycodone hydrochloride 15 mg tablet under fed conditions

• Experimental: Treatment A
  Intervention: Drug: oxycodone hydrochloride
• Experimental: Treatment B
  Intervention: Drug: oxycodone hydrochloride
• Experimental: Treatment C
  Intervention: Drug: oxycodone hydrochloride
• Experimental: Treatment D
  Intervention: Drug: oxycodone hydrochloride
• Experimental: Treatment E
  Intervention: Drug: marketed oxycodone hydrochloride

Inclusion Criteria:

• Healthy male or female subjects between 18 and 55 years of age (inclusive)

Exclusion Criteria:

• Evidence or history of clinically significant disease;
• History of obstructive sleep apnea;
• Positive urine drug test.