Phase 1 Oral Solution and Crushed Tablet Relative Bioavailability Study of Apixaban When Administered Through a Nasogastric Tube in Healthy Subjects

NCT02034591 ↗

Phase 1 Completed 37 enrolled Bristol-Myers Squibb Pfizer · collab

RandomizedCrossoverOpen-labelBasic science

Summary

The purpose of this study is to assess the bioavailability of Apixaban oral solution administered through an Nasogastric Tube (NGT) in the presence of Boost® Plus and Apixaban administered as crushed tablet through a nasogastric tube relative to Apixaban solution administered orally in healthy subjects.

Timeline

Start: 2011-10
Primary completion: 2011-11
Completion: 2011-11

Outcome

Missed primary endpoint

paper The 90% CIs of the GMRs of all AUCs met the bioequivalence criterion except that of the nutritional supplement (0.766-0.863). PMID 26188837 ↗

registry Ratio of Adjusted Geometric Means 0.682 (90% CI 0.621 to 0.748) NCT02034591 ↗

registry Ratio of Adjusted Geometric Means 0.813 (90% CI 0.766 to 0.863) NCT02034591 ↗

Publications

Song Y, Wang X, Perlstein I, Wang J, Badawy S, Frost C, LaCreta F. Relative Bioavailability of Apixaban Solution or Crushed Tablet Formulations Administered by Mouth or Nasogastric Tube in Healthy Subjects. Clin Ther. 2015 Aug;37(8):1703-12. doi: 10.1016/j.clinthera.2015.05.497. Epub 2015 Jul 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Apixaban	Small molecule	5 mg	Oral

Indications

No indication recorded.