Conditions: Thrombosis
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 69
Healthy volunteers: yes

Brief 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.

Detailed description:
This study will investigate the bioavailability of apixaban administered as crushed tablets suspended in water and as crushed tablets mixed with applesauce compared with that of whole tablets. The study results may allow enhancement of the apixaban label to include alternative methods of apixaban administration, which may be of benefit to patients who have difficulty swallowing.

Arms:
arm 1: Participants received a single dose of apixaban, 10 mg, given orally as 2 5-mg whole commercial tablets (reference) arm 2: Participants received a single dose of apixaban, 10 mg, given by mouth as 2 5-mg whole commercial tablets crushed and suspended in 30 mL of water arm 3: Participants received a single dose of 10 mg, given by mouth as 2 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce

Interventions: intervention 1: Apixaban
Intervention descriptions: intervention 1: None

Protocol document: