Drug-Drug Interaction Study to Assess the Effects of Steady State Pitavastatin 4 mg or Rosuvastatin 40 mg on Steady-State Warfarin in Healthy Adult Volunteers

Drug-Drug Interaction Study to Assess the Effects of Steady State Pitavastatin 4 mg or Rosuvastatin 40 mg on Steady-State Warfarin in Healthy Adult Volunteers

This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug interaction study.

Inclusion Criteria:

• Subject is a healthy adult male or female volunteer aged 18 to 45 years, inclusive
• Subject has a body mass index of 18 to 32 kg/m2, inclusive
• Subject is able and willing to abstain from alcohol, grapefruit, caffeine
• Subject has no clinically relevant abnormalities on the basis of medical history, physical examination, and vital signs

Exclusion Criteria:

• Subject has clinically relevant out-of-range prothrombin time (PT), activated partial thromboplastin time, fibrinogen, protein C, or protein S
• Subject has abnormal prolongation of bleeding time at Screening
• Subject has hematuria on urinalysis
• Subject has personal or family history of coagulation or bleeding disorders