Effects of Statins on the Pharmacokinetics for Midazolam... | NCT00716846

Studies
Effects of Statins on the Pharmacokinetics for Midazolam in Healthy Volunteers

NCT00716846

Sponsor

Hamamatsu University

Status

Completed

Last Update Posted

Sep 7, 2011Estimated

Enrollment

11Actual

Phase

Not Applicable

Conditions

Healthy Volunteers

Interventions

simvastatin
atorvastatin
pitavastatin

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Jul 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Jul 10, 2008

First Submission Date that Met QC Criteria

Jul 14, 2008

First Posted Date

Jul 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2011

Last Update Posted Date

Sep 7, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
statin-1	Active Comparator	simvastatin	Drug: simvastatin
statin-2	Active Comparator	atorvastatin	Drug: atorvastatin
statin-3	Active Comparator	pitavastatin	Drug: pitavastatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
simvastatin	Drug	10mg, 2 weeks	statin-1	Lipovas tablets

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the pharmacokinetics of oral midazolam		after 14-days treatment with statins

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hiroshi Watanabe, MD,PhD	Hamamatsu University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hamamatsu University School of Medicine		Hamamatsu			Japan

Intervention Browse Module

MeSH Terms

ID	Term
D019821	Simvastatin
D000069059	Atorvastatin
C108475	pitavastatin

Ancestor Terms

ID	Term
D008148	Lovastatin
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided