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

September 5, 2011 updated by: Naoki Inui, Hamamatsu University

Effects of Three Statins, Simvastatin, Atorvastatin, and Pitavastatin, on the Pharmacokinetics for Midazolam in Healthy Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hamamatsu, Japan
        • Hamamatsu University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the pharmacokinetics of oral midazolam
Time Frame: after 14-days treatment with statins
after 14-days treatment with statins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamamatsu University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

July 10, 2008

First Submitted That Met QC Criteria

July 14, 2008

First Posted (Estimate)

July 16, 2008

Study Record Updates

Last Update Posted (Estimate)

September 7, 2011

Last Update Submitted That Met QC Criteria

September 5, 2011

Last Verified

March 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hamamatsu 18-21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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