Phase 1 Bioavailability Study of Apixaban Solution Formulation Relative to Apixaban Tablets in Healthy Subjects

NCT02034565 ↗

Phase 1 Completed 48 enrolled Bristol-Myers Squibb Pfizer · collab

RandomizedCrossoverOpen-labelBasic science

Summary

The purpose of this study is to assess the oral bioavailability of Apixaban solution formulation (Treatment B, 10 mg as 25 mL x 0.4 mg/mL) relative to Apixaban tablets (Treatment A, 10 mg as 2 x 5 mg tablets) in healthy subjects.

Timeline

Start: 2010-02
Primary completion: 2010-03
Completion: 2010-03

Publications

Results 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	10 mg	Oral

Indications

No indication recorded.