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Trial record 32 of 232 for:    warfarin AND International

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01178853
Recruitment Status : Completed
First Posted : August 10, 2010
Results First Posted : October 8, 2012
Last Update Posted : October 8, 2012
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Warfarin Drug: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD) Drug: Warfarin 5 mg + Pitavastatin 4mg once daily (QD) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : July 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pitavastatin/Rosuvastatin Drug: Warfarin
Warfarin 5 mg once daily

Drug: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)
Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)

Drug: Warfarin 5 mg + Pitavastatin 4mg once daily (QD)
Warfarin 5 mg + Pitavastatin 4mg

Experimental: Rosuvastatin/Pitavastatin Drug: Warfarin
Warfarin 5 mg once daily

Drug: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)
Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)

Drug: Warfarin 5 mg + Pitavastatin 4mg once daily (QD)
Warfarin 5 mg + Pitavastatin 4mg




Primary Outcome Measures :
  1. Percent Mean Change From Baseline of International Normalized Ratio (INR) [ Time Frame: 22 Days ]
    INR is the ratio of a patient's prothrombin time to a standard, raised to the power of the ISI value for the tissue factor reagent used (INR = (PT-Test/PT-Normal)^ISI)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01178853


Locations
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United States, Texas
Austin, Texas, United States
Sponsors and Collaborators
Kowa Research Institute, Inc.

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Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01178853    
Other Study ID Numbers: NK-104-4.03US
First Posted: August 10, 2010    Key Record Dates
Results First Posted: October 8, 2012
Last Update Posted: October 8, 2012
Last Verified: September 2012
Keywords provided by Kowa Research Institute, Inc.:
Healthy Volunteers
Additional relevant MeSH terms:
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Warfarin
Rosuvastatin Calcium
Pitavastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anticoagulants