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Comparison of the Pharmacokinetics of Oxycodone Administered in Three Percocet® Formulations
Author(s) -
Gammaitoni Arnold R.,
Davis Matthew W.
Publication year - 2002
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/00912700222011238
Subject(s) - oxycodone , pharmacokinetics , medicine , cmax , crossover study , adverse effect , nausea , vomiting , anesthesia , acetaminophen , pharmacology , bioequivalence , opioid , placebo , receptor , alternative medicine , pathology
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 were separated by washout periods of at least 7 days, in each subject. Oxycodone AUC0 o‐v AUC0 o‐∞ and C max were dose dependent, whereas t max and t 1/2 were 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.