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Background  The objective of this study was to compare the pharmacokinetic profile of a novel, once-daily, controlled-release formulation of hydromorphone (OROS ®  hydromorphone) under fasting conditions with that immediately after a high-fat breakfast in healthy volunteers. The effect of the opioid antagonist naltrexone on fasting hydromorphone pharmacokinetics also was evaluated.    Methods  In an open-label, three-way, crossover study, 30 healthy volunteers were randomized to receive a single dose of 16 mg OROS ®  hydromorphone under fasting conditions, 16 mg OROS ®  hydromorphone under fed conditions, or 16 mg OROS ®  hydromorphone under fasting conditions with a naltrexone 50-mg block. Plasma samples taken pre-dose and at regular intervals up to 48 hours post-dose were assayed for hydromorphone concentrations. Analysis of variance was performed on log-transformed data; for mean ratios of 0.8 to 1.2 (20%), differences were considered minimal. Bioequivalence was reached if 90% confidence intervals (CI) of treatment mean ratios were between 80% and 125%.    Results  The mean geometric ratios of the fed and fasting treatment groups for maximum plasma concentration (C max ) and area under the concentration-time curve (AUC 0-t ; AUC 0-∞ ) were within 20%. Confidence intervals were within 80% to 125% for AUC 0-t  and AUC 0-∞  but were slightly higher for C max  (105.9% and 133.3%, respectively). With naltrexone block, the hydromorphone C max  increased by 39% and the terminal half-life decreased by 4.5 hours. There was no significant change in T max , AUC 0-t  or AUC 0-∞ .    Conclusion  Standard bioavailability measures show minimal effect of food on the bioavailability of hydromorphone from OROS ®  hydromorphone. Naltrexone co-administration results in a slight increase in the rate of absorption but not the extent of absorption.    Trial Registration  Clinical Trials.gov NCT00399295

Pharmacokinetic profile of a 24-hour controlled-release OROS® formulation of hydromorphone in the presence and absence of food