The primary objective of this study is to evaluate whether ASA 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
24
oral
oral
SGS Aster
Paris, France
Composite assessment of pharmacodynamics of darexaban and darexaban glucuronide
Assessment includes skin bleeding time, factor Xa, platelet aggregation, thromboxane B2 synthesis, PT \& aPTT
Time frame: Baseline and after six days of dosing of darexaban, ASA, or a combination of the two
Pharmacokinetics of darexaban and darexaban glucuronide assessed by plasma concentration
Time frame: Plasma samples are taken until 24 hours after six days of dosing of darexaban, or the combination with ASA
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 3 treatment periods
Pharmacokinetics of ASA assessed by plasma concentration
Time frame: Plasma samples are taken until 2 hours after six days of dosing of ASA, or the combination with darexaban
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.