Effects of Statins on the Pharmacokinetics for Midazolam in Healthy Volunteers

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: simvastatin; Drug: atorvastatin; Drug: pitavastatin

• Registration Number: NCT00716846
• Lead Sponsor: Hamamatsu University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2008-07
• Study First Submitted: 2008-07-10
• Study First Submitted QC: 2008-07-14
• Study First Posted: 2008-07-16
• Study Completion: 2008-08
• Status Verified: 2009-03
• Last Update Submitted: 2011-09-05
• Last Update Posted: 2011-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
statin-1	simvastatin	simvastatin
statin-2	atorvastatin	atorvastatin
statin-3	pitavastatin	pitavastatin

Primary Outcome Measures

Name	Time	Method
the pharmacokinetics of oral midazolam	after 14-days treatment with statins

Trial Locations

Locations (1)

Hamamatsu University School of Medicine; 🇯🇵 Hamamatsu, Japan