(427) Single-dose pharmacokinetics, bioavailability, and safety of 2 tablets of MNK-155, an extended-release hydrocodone bitartrate and acetaminophen combination analgesic (HB/APAP ER), under fed and fasted conditions

Abstract

MNK-155 is a bilayer, immediate-release (IR)/extended-release (ER) tablet formulation of hydrocodone bitartrate 7.5 mg/acetaminophen 325 mg (HB/APAP ER), utilizing gastroretentive drug delivery technology. MNK-155 is currently under development for the management of moderate to moderately severe acute pain. The purpose of this study was to evaluate the effect of fed (high- and low-fat meals) versus fasted conditions on single-dose pharmacokinetics and bioavailability following administration of MNK-155 (HB 7.5 mg/APAP 325 mg) given as 2 tablets.