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- W4313521892 abstract "Abstract Background: The impact of pancreaticoduodenectomy (PD) on absorption of drugs in the duodenum remains largely unknown. We aim to characterize the pharmacokinetics of apixaban in patients who have previously underwent PD. Methods: A single 10 mg dose of apixaban was administered to four volunteers who underwent PD at least 6 months prior. The maximum plasma apixaban concentration (C max ) and area under the plasma concentration time-curve (AUC 0-24, AUC 0-inf ) were compared against healthy historical control subjects (N=12). Geometric mean ratios (GMR) with 90% confidence interval (CI) were calculated for determination of comparative bioequivalence. Results: In PD patients AUC 0-24 and AUC 0-inf were 1861 and 2080 ng•hr/mL, respectively. The GMRs of AUC 0-24 and AUC 0-inf between study subjects and healthy controls were 1.27 (90% CI 0.88-1.83) and 1.18 (90% CI 0.82-1.72). The mean C max of apixaban was 201 ng/mL (SD 15.6) occurring at a median T max of 3.25 hours (range 2.5-4 hours). The GMR of C max between study subjects and healthy controls was 1.12 (90% CI 0.77-1.63). Conclusions: The pharmacokinetic characteristics of apixaban in subjects who have undergone PD are not significantly different from those of healthy controls. No changes in their dosing regimen are recommended. ClinicalTrials.gov Identifier: NCT04191928" @default.
- W4313521892 created "2023-01-06" @default.
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- W4313521892 date "2023-01-03" @default.
- W4313521892 modified "2023-10-16" @default.
- W4313521892 title "Pharmacokinetics of Apixaban in Patients Undergoing Pancreaticoduodenectomy (PAP-UP)" @default.
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- W4313521892 doi "https://doi.org/10.21203/rs.3.rs-2416574/v1" @default.
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