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