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NCT00716846 Clinical Trial

Effects of Statins on the Pharmacokinetics for Midazolam in Healthy Volunteers

Healthy Volunteers Clinical Trial

— H-17-21  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00716846
Other study ID # Hamamatsu 18-21
Secondary ID
Status Completed
Phase N/A
First received July 10, 2008
Last updated September 5, 2011
Start date June 2006
Est. completion date August 2008

Study information
Verified date March 2009
Source Hamamatsu University
Contact n/a
Is FDA regulated No
Health authority Japan: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date August 2008
Est. primary completion date July 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• simvastatin
10mg, 2 weeks
• atorvastatin
10mg
• pitavastatin
2mg

Locations
Country Name City State
Japan Hamamatsu University School of Medicine Hamamatsu

Sponsors (1)
Lead Sponsor Collaborator
Hamamatsu University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary the pharmacokinetics of oral midazolam after 14-days treatment with statins No
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