The primary objective of this study is to evaluate whether naproxen 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
26
SGS Aster
Paris, France
Assessment of pharmacodynamics of naproxen
Time frame: Baseline and 3 hours after multiple dosing (darexaban: 6 days, naproxen: 4 days) of darexaban, naproxen, or a combination of the two
Assessment of pharmacodynamics of darexaban
Time frame: Baseline and 3 hours after multiple dosing (darexaban: 6 days, naproxen: 4 days) of darexaban, naproxen, or a combination of the two
Pharmacokinetics of darexaban assessed by plasma concentration
Time frame: Plasma samples are taken until 24 hours after six days of dosing of darexaban, or the combination with naproxen
Pharmacokinetics of naproxen assessed by plasma concentration
Time frame: Plasma samples are taken until 12 hours after four days of dosing of naproxen, 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 treatment periods with darexaban) or 4 days. (naproxen alone)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.