Status:
COMPLETED
Drug-Drug Interaction of Cardizem LA (Diltiazem Hydrochloride) on Pitavastatin
Lead Sponsor:
Kowa Research Institute, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE4
Brief 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. Durin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01422382
Start Date
May 1 2011
End Date
July 1 2011
Last Update
July 13 2012
Active Locations (1)
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1
Austin, Texas, United States