Conditions: Healthy
Keywords: Healthy Volunteers
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 28
Healthy volunteers: yes

Brief summary:
This is a Phase 4, single-center, open-label, fixed-sequence, multiple-dose, 2-way drug-drug interaction study.

Detailed description:
Each subject will qualify for entry into the study not more than 30 days prior to admission into the clinical unit. Subjects will check into the clinical unit on Day -1 for baseline assessments. During the treatment period, each subject will receive a once-daily dose of pitavastatin 4 mg on Days 1 through 5 and on Days 11 through 15 and a once-daily dose of diltiazem 240 mg on Days 6 through 15. Subjects will fast overnight for at least 8 hours before dosing and will remain fasted until 4 hours after dosing on the morning of Days 5, 10, and 15.

Arms:
arm 1: There was 1 treatment period, with each subject receiving a once-daily dose of pitavastatin 4 mg on Days 1 through 5 and on Days 11 through 15 and a once-daily dose of diltiazem 240 mg on Days 6 through 15

Interventions: intervention 1: Pitavastatin (NK-104) intervention 2: Diltiazem (Cardizem LA) 240 mg QD
Intervention descriptions: intervention 1: pitavastatin (NK-104) 4 mg once daily (QD) intervention 2: Diltiazem (Cardizem LA) 240 mg QD

Protocol document: