Effects of Statins on the Pharmacokinetics for Midazolam in Healthy Volunteers

NCT ID: NCT00716846

Last Updated: 2011-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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statin-1

simvastatin

Group Type ACTIVE_COMPARATOR

simvastatin

Intervention Type DRUG

10mg, 2 weeks

statin-2

atorvastatin

Group Type ACTIVE_COMPARATOR

atorvastatin

Intervention Type DRUG

10mg

statin-3

pitavastatin

Group Type ACTIVE_COMPARATOR

pitavastatin

Intervention Type DRUG

2mg

Interventions

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simvastatin

10mg, 2 weeks

Intervention Type DRUG

atorvastatin

10mg

Intervention Type DRUG

pitavastatin

2mg

Intervention Type DRUG

Other Intervention Names

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Lipovas tablets Lipitor tablets Livalo tablets

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hamamatsu University

OTHER

Sponsor Role lead

Responsible Party

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Naoki Inui

Clinical Pharmacology and Therapeutics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hiroshi Watanabe, MD,PhD

Role: STUDY_CHAIR

Hamamatsu University

Locations

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Hamamatsu University School of Medicine

Hamamatsu, , Japan

Site Status

Countries

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Japan

Other Identifiers

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Hamamatsu 18-21

Identifier Type: -

Identifier Source: org_study_id

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