SGS Aster
Paris, 75015, France
NCT Number: NCT01409603
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.
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Notify Me18 year–55 year
Male
Interventional
Phase 1
Paris, 75015, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
oral
Other names: YM150
oral
Other names: Naprosyne
Time frame: Baseline and 3 hours after multiple dosing (darexaban: 6 days, naproxen: 4 days) of darexaban, naproxen, or a combination of the two
Time frame: Baseline and 3 hours after multiple dosing (darexaban: 6 days, naproxen: 4 days) of darexaban, naproxen, or a combination of the two
Time frame: Plasma samples are taken until 24 hours after six days of dosing of darexaban, or the combination with naproxen
Time frame: Plasma samples are taken until 12 hours after four days of dosing of naproxen, or the combination with darexaban
Time frame: 6 days (for treatment periods with darexaban) or 4 days. (naproxen alone)
Astellas Pharma Inc
Industry
A Phase I, Open-Label, Randomized 3-Period Crossover Study in Healthy Male Subjects to Evaluate the Pharmacodynamic Interactions Between YM150 on Naproxen at Steady-State
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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