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Effects of Statins on the Pharmacokinetics for Midazolam in Healthy Volunteers (H-17-21)

This study has been completed.
Information provided by (Responsible Party):
Naoki Inui, Hamamatsu University Identifier:
First received: July 10, 2008
Last updated: September 5, 2011
Last verified: March 2009

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.

Condition Intervention
Healthy Volunteers
Drug: simvastatin
Drug: atorvastatin
Drug: pitavastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Three Statins, Simvastatin, Atorvastatin, and Pitavastatin, on the Pharmacokinetics for Midazolam in Healthy Volunteers

Resource links provided by NLM:

Further study details as provided by Hamamatsu University:

Primary Outcome Measures:
  • the pharmacokinetics of oral midazolam [ Time Frame: after 14-days treatment with statins ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: June 2006
Study Completion Date: August 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: statin-1
Drug: simvastatin
10mg, 2 weeks
Other Name: Lipovas tablets
Active Comparator: statin-2
Drug: atorvastatin
Other Name: Lipitor tablets
Active Comparator: statin-3
Drug: pitavastatin
Other Name: Livalo tablets


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00716846

Hamamatsu University School of Medicine
Hamamatsu, Japan
Sponsors and Collaborators
Hamamatsu University
Study Chair: Hiroshi Watanabe, MD,PhD Hamamatsu University
  More Information

No publications provided

Responsible Party: Naoki Inui, Clinical Pharmacology and Therapeutics, Hamamatsu University Identifier: NCT00716846     History of Changes
Other Study ID Numbers: Hamamatsu 18-21
Study First Received: July 10, 2008
Last Updated: September 5, 2011
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on November 27, 2014