Effects of Statins on the Pharmacokinetics for Midazolam in Healthy Volunteers

Hamamatsu University11 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

simvastatinDRUG

10mg, 2 weeks

atorvastatinDRUG

10mg

pitavastatinDRUG

2mg

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Hamamatsu University School of Medicine

Hamamatsu, Japan

Outcomes

Primary Outcomes

the pharmacokinetics of oral midazolam

Time frame: after 14-days treatment with statins

Data from ClinicalTrials.gov

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