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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00716846
Recruitment Status : Completed
First Posted : July 16, 2008
Last Update Posted : September 7, 2011
Information provided by (Responsible Party):
Naoki Inui, 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: simvastatin Drug: atorvastatin Drug: pitavastatin Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Three Statins, Simvastatin, Atorvastatin, and Pitavastatin, on the Pharmacokinetics for Midazolam in Healthy Volunteers
Study Start Date : June 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : August 2008

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. the pharmacokinetics of oral midazolam [ Time Frame: after 14-days treatment with statins ]

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00716846

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

Responsible Party: Naoki Inui, Clinical Pharmacology and Therapeutics, Hamamatsu University Identifier: NCT00716846     History of Changes
Other Study ID Numbers: Hamamatsu 18-21
First Posted: July 16, 2008    Key Record Dates
Last Update Posted: September 7, 2011
Last Verified: March 2009

Additional relevant MeSH terms:
Atorvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents