Effects of Statins 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.

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Key information

Conditions

Healthy Volunteers

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamamatsu University School of Medicine

Hamamatsu, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

simvastatin

Drug

10mg, 2 weeks

Other names: Lipovas tablets

atorvastatin

Drug

10mg

Other names: Lipitor tablets

Pitavastatin

Drug

2mg

Other names: Livalo tablets

Primary outcomes

the pharmacokinetics of oral midazolam

Time frame: after 14-days treatment with statins

Sponsors and collaborators

Lead sponsor

Hamamatsu University

Other

Registry information

Official study title

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

Acronym: H-17-21

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Jul 16, 2008
Registry last updated: Sep 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed