Phase 4
N=28
Drug-Drug Interaction of Cardizem LA (Diltiazem Hydrochloride) on Pitavastatin
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01422382 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Apr 2012
Primary outcome: Primary: NK-104 AUC — 208.92 ng * h/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pitavastatin (NK-104) (Drug); Diltiazem (Cardizem LA) 240 mg QD (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kowa Research Institute, Inc.
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY NK-104 AUC |
208.92 | — |
| SECONDARY Number of Participants With at Least One Adverse Event. |
12 | — |
Summary
This is a Phase 4, single-center, open-label, fixed-sequence, multiple-dose, 2-way drug-drug interaction study.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01422382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.