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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Naoki Inui, Hamamatsu University

ClinicalTrials.gov Identifier:

NCT00716846

First received: July 10, 2008

Last updated: September 5, 2011

Last verified: March 2009

History of Changes

Purpose

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:

MedlinePlus related topics: Statins

Drug Information available for: Midazolam hydrochloride Simvastatin Atorvastatin calcium Pitavastatin

U.S. FDA Resources

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 simvastatin	Drug: simvastatin 10mg, 2 weeks Other Name: Lipovas tablets
Active Comparator: statin-2 atorvastatin	Drug: atorvastatin 10mg Other Name: Lipitor tablets
Active Comparator: statin-3 pitavastatin	Drug: pitavastatin 2mg Other Name: Livalo tablets

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716846

Locations

Japan
Hamamatsu University School of Medicine
Hamamatsu, Japan

Sponsors and Collaborators

Hamamatsu University

Investigators

Study Chair:

Hiroshi Watanabe, MD,PhD

Hamamatsu University

More Information

No publications provided

Responsible Party:	Naoki Inui, Clinical Pharmacology and Therapeutics, Hamamatsu University
ClinicalTrials.gov 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:

Midazolam
Simvastatin
Atorvastatin
Pitavastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs

Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013

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