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CompletedNCT01178853

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
48 (actual)
Sponsor
Kowa Research Institute, Inc. · Industry
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Accepted

Summary

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

Conditions

Interventions

TypeNameDescription
DRUGWarfarinWarfarin 5 mg once daily
DRUGWarfarin 5mg + Rosuvastatin 40 mg once daily (QD)Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)
DRUGWarfarin 5 mg + Pitavastatin 4mg once daily (QD)Warfarin 5 mg + Pitavastatin 4mg

Timeline

Start date
2010-07-01
Primary completion
2010-10-01
Completion
2011-04-01
First posted
2010-08-10
Last updated
2012-10-08
Results posted
2012-10-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01178853. Inclusion in this directory is not an endorsement.

Drug-Drug Interaction Study to Assess the Effects of Steady State Pitavastatin 4 mg or Rosuvastatin 40 mg on Steady-Stat (NCT01178853) · Clinical Trials Directory