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

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: Warfarin; Drug: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD); Drug: Warfarin 5 mg + Pitavastatin 4mg once daily (QD)

• Registration Number: NCT01178853
• Lead Sponsor: Kowa Research Institute, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-08-09
• Study First Submitted QC: 2010-08-09
• Study First Posted: 2010-08-10
• Primary Completion: 2010-10
• Study Completion: 2011-04
• Results First Submitted: 2012-03-29
• Status Verified: 2012-09
• Results First Submitted QC: 2012-09-06
• Last Update Submitted: 2012-09-06
• Results First Posted: 2012-10-08
• Last Update Posted: 2012-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Rosuvastatin/Pitavastatin	Warfarin 5 mg + Pitavastatin 4mg once daily (QD)	-
Pitavastatin/Rosuvastatin	Warfarin	-
Pitavastatin/Rosuvastatin	Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)	-
Pitavastatin/Rosuvastatin	Warfarin 5 mg + Pitavastatin 4mg once daily (QD)	-
Rosuvastatin/Pitavastatin	Warfarin	-
Rosuvastatin/Pitavastatin	Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)	-

Primary Outcome Measures

Name	Time	Method
Percent Mean Change From Baseline of International Normalized Ratio (INR)	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)