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

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ClinicalTrials.gov Identifier: NCT01422382
Recruitment Status : Completed
First Posted : August 24, 2011
Results First Posted : April 12, 2012
Last Update Posted : July 13, 2012
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Pitavastatin (NK-104) Drug: Diltiazem (Cardizem LA) 240 mg QD Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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 Start Date : May 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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
Drug: Pitavastatin (NK-104)
pitavastatin (NK-104) 4 mg once daily (QD)
Other Name: Livalo
Drug: Diltiazem (Cardizem LA) 240 mg QD
Diltiazem (Cardizem LA) 240 mg QD



Primary Outcome Measures :
  1. NK-104 AUC [ Time Frame: 15 Days ]

Secondary Outcome Measures :
  1. Number of Participants With at Least One Adverse Event. [ Time Frame: 24 Days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01422382


Locations
United States, Texas
Austin, Texas, United States
Sponsors and Collaborators
Kowa Research Institute, Inc.
Investigators
Study Director: Roger Morgan, MD, FACS Kowa Research Institute, Inc.

Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01422382     History of Changes
Other Study ID Numbers: NK-104-4.07US
First Posted: August 24, 2011    Key Record Dates
Results First Posted: April 12, 2012
Last Update Posted: July 13, 2012
Last Verified: July 2012

Keywords provided by Kowa Research Institute, Inc.:
Healthy Volunteers

Additional relevant MeSH terms:
Pitavastatin
Diltiazem
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents