The primary objective of this study is to evaluate whether ASA, the combination of ASA and clopidogrel, and darexaban, which have different effects on blood coagulation, influence each other in their effects. Also it will be investigated whether the blood levels of either drug are influenced by the presence of the other drug. In addition, the safety and tolerability of each drug and the combination of the drugs will be investigated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
100
oral
oral
oral
oral
SGS Aster
Paris, France
Assessment of pharmacodynamics of darexaban
Time frame: Baseline and up to 24 hours after six days of dosing of darexaban, ASA, clopidogrel, or a combination
Assessment of pharmacodynamics of ASA and a combination of ASA and clopidogrel
Time frame: Baseline and up to 24 hours after six days of dosing of darexaban, ASA, clopidogrel, or a combination
Pharmacokinetics of ASA and the combination of ASA and clopidogrel assessed by plasma concentration
Time frame: Plasma samples are taken until 24 hours after six days of dosing of ASA, a combination of ASA and clopidogrel, or the combination with darexaban
Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events
Time frame: 6 days for each of the 2 treatment periods
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.