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. 2021 Jun 25;9(1):e002208. doi: 10.1136/bmjdrc-2021-002208

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© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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(A) Baseline-adjusted acetaminophen concentrations over time (PK population). Data are LS geometric mean (calculated using SAS procedure GLM (general linear model)) adjusted for baseline concentration at the corresponding time point, separately by treatment. Blood acetaminophen concentrations were determined at –0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5 and 6 hours after the meal. To account for the pre-study drug differences for PK/PD parameters, baseline-adjusted PK parameters were used; these are post hoc analyses. Acetaminophen (B) AUC_0–180, (C) AUC_0–360 and (D) C_max at peak concentrations adjusted for baseline values (PK population). The placebo groups from cohort A and cohort B were pooled. AUC, area under the curve; C_max, maximum concentration; LS, least squares; PD, pharmacodynamic; PK, pharmacokinetic; QM, once monthly; QW, once weekly.