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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00716846
First Posted: July 16, 2008
Last Update Posted: September 7, 2011
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.
Information provided by (Responsible Party):
Naoki Inui, Hamamatsu University
  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
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

Resource links provided by NLM:


Further study details as provided by Naoki Inui, Hamamatsu University:

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Naoki Inui, Clinical Pharmacology and Therapeutics, Hamamatsu University
ClinicalTrials.gov Identifier: NCT00716846     History of Changes
Other Study ID Numbers: Hamamatsu 18-21
First Submitted: July 10, 2008
First Posted: July 16, 2008
Last Update Posted: September 7, 2011
Last Verified: March 2009

Additional relevant MeSH terms:
Atorvastatin Calcium
Simvastatin
Pitavastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Midazolam
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
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
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents