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A Randomized Study of the Effects of Food on the Pharmacokinetics of Once‐Daily Extended‐Release Hydromorphone in Healthy Volunteers
Author(s) -
Moore Kenneth Todd,
StFleur Dominique,
Marricco Nadia Cardillo,
Ariyawansa Jay,
Pagé Véronique,
Natarajan Jayalakshmi,
Morelli Gaetano,
Richarz Ute
Publication year - 2011
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 - 10.1177/0091270010383858
Subject(s) - hydromorphone , pharmacokinetics , bioequivalence , cmax , bioavailability , crossover study , anesthesia , medicine , pharmacology , opioid , placebo , receptor , alternative medicine , pathology
This randomized, open‐label, crossover study investigated the influence of food on the pharmacokinetics of extended‐release hydromorphone in 30 healthy volunteers. Participants received extended‐release hydromorphone 16 mg in the fasted state and immediately after a high‐fat breakfast. In addition, the pharmacokinetics of a 16‐mg dose of extended‐release hydromorphone and a 16‐mg daily dose (4 mg qid) of immediate‐release hydromorphone in the fasted state were compared. Treatments were separated by washout periods of 7 to 14 days. Naltrexone was given throughout each treatment period to block the opioid effects of hydromorphone. The 90% confidence intervals (CIs) of the ratios of geometric means for maximum plasma concentrations (C max ) and area under the plasma concentration‐time curve (AUC) for extended‐release hydromorphone in the fed and fasted states were within the bioequivalence criteria range of 80% to 125%. In the fasted state, the 90% CIs of the ratios of AUC geometric means for extended‐release hydromorphone and immediate‐release hydromorphone were also within the bioequivalence range. Both hydromorphone treatments were well tolerated. This study shows that the bioavailability of extended‐release hydromorphone is not affected by food and that the bioavailability of extended‐release hydromorphone under fasting conditions is comparable with that of the immediate‐release formulation when administered at the same total daily dose.