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H-17-21: Effects of Statins on the Pharmacokinetics for Midazolam in Healthy Volunteers

Sponsor
Hamamatsu University (Other)
Overall Status
Completed
CT.gov ID
NCT00716846
Collaborator
(none)
11
Enrollment
1
Location
3
Arms
26
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate whether statins have any influence on cytochrome P450 (CYP) 3A4 enzyme activity using a probe drug midazolam.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Three Statins, Simvastatin, Atorvastatin, and Pitavastatin, on the Pharmacokinetics for Midazolam in Healthy Volunteers
Study Start Date :
Jun 1, 2006
Actual Primary Completion Date :
Jul 1, 2008
Actual Study Completion Date :
Aug 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: statin-1

simvastatin

Drug: simvastatin
10mg, 2 weeks
Other Names:
  • Lipovas tablets

    		•
    Active Comparator: statin-2

    atorvastatin

    Drug: atorvastatin
    10mg
    Other Names:
  • Lipitor tablets

    		•
    Active Comparator: statin-3

    pitavastatin

    Drug: pitavastatin
    2mg
    Other Names:
  • Livalo tablets

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the pharmacokinetics of oral midazolam [after 14-days treatment with statins]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Volunteers in good health according to their medical history, a physical examination and standard laboratory tests
    Exclusion Criteria:
    • Subjects who have been using any continuous medication or herbal supplements.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hamamatsu University School of Medicine Hamamatsu Japan

    Sponsors and Collaborators

    • Hamamatsu University

    Investigators

    • Study Chair: Hiroshi Watanabe, MD,PhD, Hamamatsu University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Naoki Inui, Clinical Pharmacology and Therapeutics, Hamamatsu University
    ClinicalTrials.gov Identifier:
    NCT00716846
    Other Study ID Numbers:
    • Hamamatsu 18-21
    First Posted:
    Jul 16, 2008
    Last Update Posted:
    Sep 7, 2011
    Last Verified:
    Mar 1, 2009
    Additional relevant MeSH terms:
    Atorvastatin
    Simvastatin
    Pitavastatin

    Study Results

    No Results Posted as of Sep 7, 2011