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

NCT01422382 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2012-07-13

Study results available
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Summary

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

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Kowa Research Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Roger Morgan, MD, FACS · Kowa Research Institute, Inc.

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-06-30
Completion
2011-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01422382 on ClinicalTrials.gov