A single and repeat patch application study to determine what the body does to oxycodone in combination with tocopheryl phosphate mix, when delivered through the skin using a patch.

Exclusion Criteria19

• Evidence of any clinically significant impairment/disorder
• History of coronary diseases, peripheral vascular diseases, cerebrovascular accident, transient ischaemic attack, uncontrolled hypertension or signs/symptoms of ischaemic heart disease
• Current use of CNS depressants
• Use of macrolide antibiotics, azole antifungal agents or protease inhibitors within 30 days of Day 1
• A calculated creatinine clearance of < 85ml/min
• Positive HIV antibodies, Hep B surface antigen or Hep C antibody test
• History of epilepsy or any convulsive disorder
• Any pre-existing medical conditions predisposing the participant to hypoventilation or hypoxaemia including diagnosed obstructive sleep apnoea
• Systolic BP of < 90 mmHg or >140 mmHg and/or diastolic BP of < 50 mmHg or >95 mmHg
• Known intolerance to naltrexone, naloxone, oxycodone, or other opioid analgesics or any commercially available adhesives
• Any history of a recurrent generalised skin disorder <5 yrs
• Any tattoos, scars or skin lesions on the area of IP application
• History/evidence of drug or alcohol abuse and/or positive urine/breath test
• Not able to abstain from alcohol, caffeine, smoking or other xanthine-containing products
• Smoked avg. of =1 cigarettes/tobacco per mth in last 12 mths
• Use of any prescription medication, over the counter products, herbal product, diet aid, or hormone supplement 14 days prior to study dosing
• Consumption of grapefruit products, or any products containing CYP3A4 inhibitors and inducers within 14 days prior to the first day of study confinement
• Males and females of childbearing potential who are unwilling or unable to use an acceptable method of double barrier contraception
• Pregnant or lactating females.