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

Information source: Kowa Research Institute, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Pitavastatin (NK-104) (Drug); Diltiazem (Cardizem LA) 240 mg QD (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Kowa Research Institute, Inc.

Official(s) and/or principal investigator(s):
Roger Morgan, MD, FACS, Study Director, Affiliation: Kowa Research Institute, Inc.


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

Clinical Details

Official title: 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: NK-104 AUC

Secondary outcome: Number of Participants With at Least One Adverse Event.

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.


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.


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.

Locations and Contacts

Austin, Texas, United States
Additional Information

Starting date: May 2011
Last updated: July 5, 2012

Page last updated: August 23, 2015

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