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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

NCT01178853 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2012-10-08

Study results available
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Summary

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

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Kowa Research Institute, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2010-10-31
Completion
2011-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01178853 on ClinicalTrials.gov