The primary objective of the study is to determine whether aspirin alone or aspirin combined with various doses of rivaroxaban causes subclinical GI blood loss as determined by the HemoQuant assay. The secondary objective of the study is to evaluate the safety and tolerability of aspirin alone or in combination with rivaroxaban to healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
60
Administered orally once per day (QD)
Administered orally twice per day (BID)
Administered orally QD
LabCorp CRU
Leeds, West Yorkshire, United Kingdom
Change from baseline in fecal hemoglobin content as measured by HemoQuant during the second week of exposure to study medication
HemoQuant is a chemical laboratory test of fecal hemoglobin content.
Time frame: Up to Week 4
Number of bleeding events during the baseline period as compared to the treatment period
Time frame: Up to week 4
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