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

NCT ID: NCT01422382

Last Updated: 2012-07-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-07-31

Brief Summary

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

Detailed Description

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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

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Healthy

Keywords

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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All Subjects

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

Group Type EXPERIMENTAL

Pitavastatin (NK-104)

Intervention Type DRUG

pitavastatin (NK-104) 4 mg once daily (QD)

Diltiazem (Cardizem LA) 240 mg QD

Intervention Type DRUG

Diltiazem (Cardizem LA) 240 mg QD

Interventions

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Pitavastatin (NK-104)

pitavastatin (NK-104) 4 mg once daily (QD)

Intervention Type DRUG

Diltiazem (Cardizem LA) 240 mg QD

Diltiazem (Cardizem LA) 240 mg QD

Intervention Type DRUG

Other Intervention Names

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Livalo

Eligibility Criteria

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Inclusion Criteria

* Healthy adult male or female volunteer aged 18 to 45 years, inclusive.
* Subject has a body mass index of 18 to 30 kg/m2, inclusive.
* Subject has normal hematology, serum chemistry, and urinalysis test results.
* Subject is able and willing to abstain from alcohol, grapefruit-containing foods or beverages, caffeine, or caffeine-containing products, St John's wort, and herbal supplements for 4 days before Day 1 and until after completion of this study.
* Subject is a nonsmoker or has quit smoking at least 6 months before the first dose of study drug and until after study completion.

Exclusion Criteria

* Subject has had any surgery of the gastrointestinal tract likely to affect drug absorption, distribution, metabolism, or excretion.
* Subject has had a previous allergy or intolerance to treatment with pitavastatin, diltiazem, or any drugs in these classes.
* Subject has a history of drug or alcohol abuse.
* Subject has had a clinically significant illness within 4 weeks before the first dose of study drug.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kowa Research Institute, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roger Morgan, MD, FACS

Role: STUDY_DIRECTOR

Kowa Research Institute, Inc.

Locations

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Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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NK-104-4.07US

Identifier Type: -

Identifier Source: org_study_id