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

September 6, 2012 updated by: Kowa Research Institute, Inc.
This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug interaction study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
22 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kowa Research Institute, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

August 9, 2010

First Submitted That Met QC Criteria

August 9, 2010

First Posted (Estimate)

August 10, 2010

Study Record Updates

Last Update Posted (Estimate)

October 8, 2012

Last Update Submitted That Met QC Criteria

September 6, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NK-104-4.03US

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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