Status:
COMPLETED
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
Lead Sponsor:
Kowa Research Institute, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE4
Brief Summary
This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug interaction study.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01178853
Start Date
July 1 2010
End Date
April 1 2011
Last Update
October 8 2012
Active Locations (1)
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1
Austin, Texas, United States