SUBJECT PREFERENCE TESTING AND PHARMACOKINETICS OF OraVescent~(TM) FENTANYL UNDER SIMULATED SELF-ADMINISTRATION CONDITIONS

摘要

Fentanyl pharmacokinetics were compared after simulated self administration of 3 regimens: (1) sublingual (SL) OraVescent~(TM) fentanyl, (2) buccal (BL) OraVescent~(TM) fentanyl, and (3) Actiq~(~R). Preference testing was also conducted. There were no significant differences in the key pharmacokinetic parameters for OraVescent~(TM) SL or BL. AUC and C_(max) for OraVescent~(TM) were significantly higher, and T_(max) was significantly shorter, compared to the corresponding values for Actiq~(~R). The subjects preferred the taste and mouth feel of Actiq~(~R) but perceived that OraVescent~(TM) BL would have a faster onset of action.