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

Hamamatsu University

Status: Completed

Conditions: Healthy Volunteers

Treatments: Drug: pitavastatin; Drug: simvastatin; Drug: atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00716846

Hamamatsu 18-21

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

11 participants in 3 patient groups

statin-1

Active Comparator group

Description:

simvastatin

Treatment:

Drug: simvastatin

statin-2

Active Comparator group

Description:

atorvastatin

Treatment:

Drug: atorvastatin

statin-3

Active Comparator group

Description:

pitavastatin

Treatment:

Drug: pitavastatin