Phase 4
N=48
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
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01178853 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Percent Mean Change From Baseline of International Normalized Ratio (INR) — 0.0452; 0.1605 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Warfarin (Drug); Warfarin 5mg + Rosuvastatin 40 mg once daily (QD) (Drug); Warfarin 5 mg + Pitavastatin 4mg once daily (QD) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kowa Research Institute, Inc.
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Mean Change From Baseline of International Normalized Ratio (INR) |
0.0452; 0.1605 | — |
Summary
This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug interaction study.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01178853). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.