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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

NCT ID: NCT01178853

Last Updated: 2012-10-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-04-30

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Keywords

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Pitavastatin/Rosuvastatin

Group Type EXPERIMENTAL

Warfarin

Intervention Type DRUG

Warfarin 5 mg once daily

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

Intervention Type DRUG

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

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

Intervention Type DRUG

Warfarin 5 mg + Pitavastatin 4mg

Rosuvastatin/Pitavastatin

Group Type EXPERIMENTAL

Warfarin

Intervention Type DRUG

Warfarin 5 mg once daily

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

Intervention Type DRUG

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

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

Intervention Type DRUG

Warfarin 5 mg + Pitavastatin 4mg

Interventions

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Warfarin

Warfarin 5 mg once daily

Intervention Type DRUG

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

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

Intervention Type DRUG

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

Warfarin 5 mg + Pitavastatin 4mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kowa Research Institute, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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NK-104-4.03US

Identifier Type: -

Identifier Source: org_study_id