Bioavailability of Apixaban Crushed Tablet

Phase 1 Completed 69 enrolled Bristol-Myers Squibb

RandomizedCrossoverOpen-label

Summary

The purpose of this study is to determine whether the bioavailability of apixaban crushed tablets suspended in water or mixed with applesauce is similar to the bioavailability of apixaban whole tablets administered orally.

Timeline

Start: 2014-03
Primary completion: 2014-05
Completion: 2014-05

Outcome

Mixed primary results

paper Cmax and AUC met bioequivalence criteria for crushed tablets in water. PMID 27292282 ↗

paper Cmax and AUC decreased by 21.1% and 16.4%, respectively, with the lower bound of the CIs falling below the bioequivalence criteria for crushed tablets with applesauce. PMID 27292282 ↗

Publications

Song Y, Chang M, Suzuki A, Frost RJ, Kelly A, LaCreta F, Frost C. Evaluation of Crushed Tablet for Oral Administration and the Effect of Food on Apixaban Pharmacokinetics in Healthy Adults. Clin Ther. 2016 Jul;38(7):1674-1685.e1. doi: 10.1016/j.clinthera.2016.05.004. Epub 2016 Jun 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Apixaban	Small molecule	10 mg	Oral