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

Kowa

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: Warfarin; Drug: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD); Drug: Warfarin 5 mg + Pitavastatin 4mg once daily (QD)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01178853

NK-104-4.03US

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

48 participants in 2 patient groups

Pitavastatin/Rosuvastatin

Experimental group

Treatment:

Drug: Warfarin

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

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

Rosuvastatin/Pitavastatin

Experimental group

Treatment:

Drug: Warfarin

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

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