This study is to evaluate the effects of multiple-dose clarithromycin on the single-dose pharmacokinetics (PK) of apixaban with parameters like Cmax, AUC(INF), and AUC(0-T).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
Multiple-dose clarithromycin and single-dose Apixaban
Multiple-dose clarithromycin and single-dose Apixaban
Ppd Development, Llc
Austin, Texas, United States
Maximum observed concentration (Cmax)
Time frame: Days 1-11
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Days 1-11
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Time frame: Days 1-11
Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death
Time frame: Screening- until 30 days after discontinuation of dosing or subject's participation in the study if the last
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