NCT01424332

To Evaluate Whether Acetyl Salicylic Acid (Aspirin) and Darexaban (YM150) Interact in Their Effects

A Randomized, Open Label, Three-way Crossover Study to Evaluate the Pharmacodynamic Interactions Between Darexaban (YM150)/Darexaban Glucuronide (YM-222714) and Acetyl Salicylic Acid (ASA) in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Pharmacodynamic and Pharmacokinetic Interaction
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Darexaban	oral
DRUG	Acetyl Salicylic Acid (ASA)	oral

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2011-08-29
• Last updated: 2011-08-29

Locations

1 site across 1 country: France