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OpenTrials
Completed

NCT Number: NCT01178853

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

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

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Austin, Texas, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Warfarin

Drug

Warfarin 5 mg once daily

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

Drug

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

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

Drug

Warfarin 5 mg + Pitavastatin 4mg

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Kowa Research Institute, Inc.

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Aug 10, 2010
Registry last updated
Oct 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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