Single‐dose evaluation of safety, tolerability and pharmacokinetics of newly formulated hydromorphone immediate‐release and hydrophilic matrix extended‐release tablets in healthy Japanese subjects without co‐administration of an opioid antagonist

This single dose, open‐label study investigated the safety, tolerability and pharmacokinetics of single oral doses of newly formulated immediate‐release (IR) and hydrophilic matrix extended‐release (ER) hydromorphone tablets in healthy Japanese subjects without co‐administration of an opioid antagonist under fasting and fed conditions. Plasma and urinary concentrations of hydromorphone and metabolites were measured by liquid‐chromatography...