Phase 4
Completed 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
Source: ClinicalTrials.gov NCT01178853 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcomePrimary: Percent Mean Change From Baseline of International Normalized Ratio (INR) — 0.0452; 0.1605 percent change
Summary
This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug interaction study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Mean Change From Baseline of International Normalized Ratio (INR) |
0.0452; 0.1605 | — |
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. Informational only — not medical advice.