Effects of Statins on the Pharmacokinetics for Midazolam in Healthy Volunteers

Effects of Three Statins, Simvastatin, Atorvastatin, and Pitavastatin, on the Pharmacokinetics for Midazolam in Healthy Volunteers

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00716846

Acronym

H-17-21

Enrollment

Registered

2008-07-16

Start date

2006-06-30

Completion date

2008-08-31

Last updated

2011-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DRUGsimvastatin

10mg, 2 weeks

DRUGatorvastatin

10mg

DRUGpitavastatin

2mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026