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

Completed · Phase 4

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT01178853

Run by

Kowa Research Institute, Inc.

People needed

48

Starts

2010-07-01

Expected to finish

2011-04-01

Last updated by the study team

2012-10-08

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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