Comparison of the pharmacokinetics of oxycodone administered in three Percocet® formulations

This randomized, open-label, three-period crossover study, compared the single-dose pharmacokinetics of three dose levels of oxycodone in combination with acetaminophen (5 mg/325 mg, 7.5 mg/500 mg, or 10 mg/650 mg) in healthy volunteers. Serial 24-hour blood samples were collected from 23 fasting subjects after drug administration. The individual dose levels were evaluated on 3 different days, which Here separated by washout periods of at least 7 days, in each subject. Oxycodone AUC(0-t), AUC(0-infinity), and C. were dose dependent, whereas t(max) and t(1/2)vere not. The most frequently reported adverse events were dizziness, nausea, headache, pruritus, and vomiting. Most adverse events were mild, and all were self-limiting. Only dizziness occurred in a doserelated manner. Increasing dose levels of oxycodone/ acetaminophen provides proportional increases in oxycodone C-max and AUC. Adverse events were predictable based on the opioid pharmacologic actions of this agent. (C) 2002 the American College of Clinical Pharmacology.