NCT01422382

Drug-Drug Interaction of Cardizem LA (Diltiazem Hydrochloride) on Pitavastatin

Drug-Drug Interaction Study to Assess the Effects of Steady-State Cardizem LA (Diltiazem Hydrochloride) and Steady-State Pitavastatin on Their Respective Pharmacokinetics in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Kowa Research Institute, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pitavastatin (NK-104)	pitavastatin (NK-104) 4 mg once daily (QD)
DRUG	Diltiazem (Cardizem LA) 240 mg QD	Diltiazem (Cardizem LA) 240 mg QD

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-06-01
• Completion: 2011-07-01
• First posted: 2011-08-24
• Last updated: 2012-07-13
• Results posted: 2012-04-12

Locations

1 site across 1 country: United States