This analysis evaluated the single-dose population pharmacokinetics (PK) of biphasic immediate-release (IR)/extended-release (ER) @entity1288 ( @entity5708 )/ @entity1443 ( @entity1443 ) 7.5/325 mg tablets administered under fasted conditions and the effects of a meal on their single-dose population PK. Data were pooled from four randomized, single-dose crossover trials enrolling healthy adult (18-55 years old) @entity1 (three trials) and nondependent recreational users of prescription opioids (one trial) with a body weight of >= 59 kg. @entity1 received IR/ER @entity5708 / @entity1443 7.5/325 mg tablets in single doses of 7.5/325 mg (one tablet), 15/650 mg (two tablets), or 30/1,300 mg (four tablets) under fasted or fed conditions. Six variables were examined: sex, race, age, weight, height, and body mass index. Single-dose population PK was analyzed using first-order conditional estimation methods. A total of 151 @entity1 were included in the analysis under fasted conditions, and 31 @entity1 were included in the fed analysis. Under fasted conditions, a 10% change in body weight was accompanied by ~7.5% change in total body clearance (CL/F) and volume of distribution (V/F) of @entity5708 and @entity1443 . Black @entity1 had 17.3% lower CL/F and a 16.9% lower V/F of @entity5708 compared with white @entity1 . Under fed conditions, the absorption rate constant of @entity5708 and @entity1443 decreased significantly, although there was no effect on CL/F and V/F. Considering that the recommended dose for IR/ER @entity5708 / @entity1443 7.5/325 mg tablets is two tablets every 12 hours, adjustments of <50% are not clinically relevant. Dose adjustment may be necessary for large deviations from average body weight, but the small PK effects associated with race and consumption of a meal are not clinically relevant.

Pooled post hoc analysis of population pharmacokinetics of @entity1288 and @entity1443 following a single oral dose of biphasic immediate-release/extended-release @entity1288 / XXXX tablets.

@entity1 :: ('9606', 'Species') :: ['participants', 'Participants'] @entity1443 :: ('MESH:D000082', 'Chemical') :: ['acetaminophen', 'APAP'] @entity1288 :: ('MESH:D010098', 'Chemical') :: ['oxycodone'] @entity5708 :: ('D003276', 'Chemical') :: ['OC']
@entity1443 :: (MESH:D000082,Chemical) :: ['acetaminophen']
