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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Molecular Mechanisms of Pharmacological Action
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 18, 2014