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Effect of food on the comparative pharmacokinetics of modified‐release morphine tablet formulations: Oramorph SR[Note 1. This formulation differs from Oramorph SR (Roxane Labs Inc. ...] and MST Continus
Author(s) -
DRAKE J.,
KIRKPATRICK C. T.,
ALIYAR C. A.,
CRAWFORD F. E.,
GIBSON P.,
HORTH C. E.
Publication year - 1996
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1046/j.1365-2125.1996.32810.x
Subject(s) - bioequivalence , bioavailability , cmax , pharmacokinetics , meal , medicine , significant difference , pharmacology , adverse effect
The relative bioavailability and pharmacokinetic profiles of Oramorph SR (OSR) and MST Continus (MST), were evaluated by a randomized, four‐way cross‐over study in 24 healthy, male volunteers given single oral (30 mg) doses whilst fasting or after a high‐fat breakfast. Mean C max , t max , AUC(0,24h), AUC and t lag were significantly greater in fed compared with fasting subjects. Overall relative bioavailability of the two formulations (log AUC), was within the acceptable 80–125% limits for bioequivalence both fed and fasting. Mean fasting C max for OSR was greater than MST ( P <0.05) but there was no difference between formulations in mean fed C max . No statistically significant difference between OSR and MST was found for other parameters nor in the incidence of adverse events. These results suggest that OSR and MST are bioequivalent and that if patients were to transfer between formulations, dosage adjustment would be unnecessary, irrespective of their meal schedules or food intake.